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"Manipulation, Spinal"
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Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials
by
Rubinstein, Sidney M
,
van Middelkoop, Marienke
,
Assendelft, Willem J J
in
Chiropractic medicine
,
Chronic Disease - therapy
,
Clinical trials
2019
AbstractObjectiveTo assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesMedline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews.Eligibility criteria for selecting studiesRandomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting.Review methodsTwo reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months. Quality of evidence was assessed using GRADE. A random effects model was used and statistical heterogeneity explored.Results47 randomised controlled trials including a total of 9211 participants were identified, who were on average middle aged (35-60 years). Most trials compared SMT with recommended therapies. Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief (mean difference −3.17, 95% confidence interval −7.85 to 1.51) and a small, clinically better improvement in function (SMD −0.25, 95% confidence interval −0.41 to −0.09). High quality evidence suggested that compared with non-recommended therapies SMT results in small, not clinically better effects for short term pain relief (mean difference −7.48, −11.50 to −3.47) and small to moderate clinically better improvement in function (SMD −0.41, −0.67 to −0.15). In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy. Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Statistical heterogeneity could not be explained. About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event (relative risk 1.24, 95% confidence interval 0.85 to 1.81) or duration of the event (1.13, 0.59 to 2.18) compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.ConclusionSMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.
Journal Article
United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care
2004
Abstract Objective To estimate the effect of adding exercise classes, spinal manipulation delivered in NHS or private premises, or manipulation followed by exercise to “best care” in general practice for patients consulting with back pain. Fig 1 Progress of the UK BEAM trial Design Pragmatic randomised trial with factorial design. Setting 181 general practices in Medical Research Council General Practice Research Framework; 63 community settings around 14 centres across the United Kingdom. Participants 1334 patients consulting their general practices about low back pain. Main outcome measures Scores on the Roland Morris disability questionnaire at three and 12 months, adjusted for centre and baseline scores. Results All groups improved over time. Exercise improved mean disability questionnaire scores at three months by 1.4 (95% confidence interval 0.6 to 2.1) more than “best care.” For manipulation the additional improvement was 1.6 (0.8 to 2.3) at three months and 1.0 (0.2 to 1.8) at 12 months. For manipulation followed by exercise the additional improvement was 1.9 (1.2 to 2.6) at three months and 1.3 (0.5 to 2.1) at 12 months. No significant differences in outcome occurred between manipulation in NHS premises and in private premises. No serious adverse events occurred. Conclusions Relative to “best care” in general practice, manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months.
Journal Article
'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy
2025
Background
Blinding is essential for mitigating biases in trials of low back pain (LBP). Our main objectives were to assess the feasibility of blinding: (1) participants randomly allocated to active or placebo spinal manual therapy (SMT), and (2) outcome assessors. We also explored blinding by levels of SMT lifetime experience and recent LBP, and factors contributing to beliefs about the assigned intervention.
Methods
A two-parallel-arm, single-centre, placebo-controlled, blinding feasibility trial. Adults were randomised to active SMT (
n
= 40) or placebo SMT (
n
= 41). Participants attended two study visits for their assigned intervention, on average seven days apart. The primary outcome was participant blinding (beliefs about assigned intervention) using the Bang blinding index (BI) at two study visits. The Bang BI is arm-specific, chance-corrected, and ranges from − 1 (all incorrect beliefs) to 1 (all correct beliefs), with 0 indicating equal proportions of correct and incorrect beliefs. Secondary outcomes included factors contributing to beliefs about the assigned intervention.
Results
Of 85 adults screened, 81 participants were randomised (41 [51%] with SMT lifetime experience; 29 [39%] with recent LBP), and 80 (99%) completed follow-up. At study visit 1, 50% of participants in the active SMT arm (Bang BI: 0.50 [95% confidence interval (CI), 0.26 to 0.74]) and 37% in the placebo SMT arm (0.37 [95% CI, 0.10 to 0.63]) had a correct belief about their assigned intervention, beyond chance. At study visit 2, BIs were 0.36 (0.08 to 0.64) and 0.29 (0.01 to 0.57) for participants in the active and placebo SMT arms, respectively. BIs among outcome assessors suggested adequate blinding at both study visits (active SMT: 0.08 [− 0.05 to 0.20] and 0.03 [− 0.11 to 0.16]; placebo SMT: − 0.12 [− 0.24 to 0.00] and − 0.07 [− 0.21 to 0.07]). BIs varied by participant levels of SMT lifetime experience and recent LBP. Participants and outcome assessors described different factors contributing to their beliefs.
Conclusions
Adequate blinding of participants assigned to active SMT may not be feasible with the intervention protocol studied, whereas blinding of participants in the placebo SMT arm may be feasible. Blinding of outcome assessors seemed adequate. Further methodological work on blinding of SMT is needed.
Trial registration number
NCT05778396.
Journal Article
Immediate effects of spinal manipulation on painful sensitivity and postural stability in patients with chronic nonspecific low back pain: study protocol for a controlled randomised clinical trial
by
Bittencourt, Juliana Valentim
,
Freitas, João Paulo
,
Corrêa, Leticia Amaral
in
Back pain
,
Biomedicine
,
Brazil
2022
Background
Low back pain is one of the main public health concerns. Chronic low back pain (cLBP) reduces functional capacity and affects postural stability. Although health professionals widely use spinal manipulation, its immediate effect on painful sensitivity and postural stability is lacking. This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP.
Methods
A two-arm, placebo-controlled clinical trial with parallel groups and examiner-blinded will be conducted with 80 participants with cLBP from an outpatient physical therapy department, randomly allocated at a 1:1 distribution. The experimental group will receive a lumbar spinal manipulation technique, and the placebo group will receive a simulated lumbar spinal manipulation. Both groups will receive one session of treatment and will be evaluated before and immediately after the intervention. The primary outcomes will be the pressure pain threshold and postural stability. Pain intensity and patient’s expectation will be assessed as a secondary outcome. The pressure pain threshold will be assessed using a pressure algometer in 6 different anatomical regions. The evaluation of postural stability will be performed in a baropodometry exam by displacing the centre of pressure. The pain intensity will be measured using the Numeric Pain Rating Scale. A Likert scale will be used for the patient’s expectation about the treatment. A two-way analysis of variance will compare the effect of the interventions between groups.
Discussion
This study will provide insights regarding the immediate effects of spinal manipulation in patients with cLBP against a simulated spinal manipulation using objective outcomes and considering patients’ expectations regarding the treatment.
Trial registration
Brazilian Registry of Clinical Trials
RBR-3ksq2c
. Registered on 13 July 2020
Journal Article
Chiropractic treatment including instrument-assisted manipulation for non-specific dizziness and neck pain in community-dwelling older people: a feasibility randomised sham-controlled trial
by
Azari, Michael F.
,
Hartvigsen, Jan
,
French, Simon D.
in
Accidental Falls - prevention & control
,
Aged
,
Aged, 80 and over
2018
Background
Dizziness in older people is a risk factor for falls. Neck pain is associated with dizziness and responds favourably to neck manipulation. However, it is unknown if chiropractic intervention including instrument-assisted manipulation of the neck in older people with neck pain can also improve dizziness.
Methods
This parallel two-arm pilot trial was conducted in Melbourne, Australia over nine months (October 2015 to June 2016). Participants aged 65–85 years, with self-reported chronic neck pain and dizziness, were recruited from the general public through advertisements in local community newspapers and via Facebook. Participants were randomised using a permuted block method to one of two groups: 1) Activator II™-instrument-assisted cervical and thoracic spine manipulation plus a combination of: light massage; mobilisation; range of motion exercises; and home advice about the application of heat, or 2) Sham-Activator II™-instrument-assisted manipulation (set to zero impulse) plus gentle touch of cervical and thoracic spinal regions. Participants were blinded to group allocation. The interventions were delivered weekly for four weeks. Assessments were conducted one week pre- and post-intervention. Clinical outcomes were assessed blindly and included: dizziness (dizziness handicap inventory [DHI]); neck pain (neck disability index [NDI]); self-reported concerns of falling; mood; physical function; and treatment satisfaction. Feasibility outcomes included recruitment rates, compliance with intervention and outcome assessment, study location, success of blinding, costs and harms.
Results
Out of 162 enquiries, 24 participants were screened as eligible and randomised to either the chiropractic (
n
= 13) or sham (
n
= 11) intervention group. Compliance was satisfactory with only two participants lost to follow up; thus, post-intervention data for 12 chiropractic intervention and 10 sham intervention participants were analysed. Blinding was similar between groups. Mild harms of increased spinal pain or headaches were reported by 6 participants. Costs amounted to AUD$2635 per participant. The data showed a trend favouring the chiropractic group in terms of clinically-significant improvements in both NDI and DHI scores. Sample sizes of
n
= 150 or
n
= 222 for dizziness or neck pain disability as the primary outcome measure, respectively, would be needed for a fully powered trial.
Conclusions
Recruitment of participants in this setting was difficult and expensive. However, a larger trial may be feasible at a specialised dizziness clinic within a rehabilitation setting. Compliance was acceptable and the outcome measures used were well accepted and responsive.
Trial registration
Australian New Zealand Clinical Trials Registry (ANZCTR)
ACTRN12613000653763
. Registered 13 June 2013.
Trial funding: Foundation for Chiropractic Research and Postgraduate Education (Denmark).
Journal Article
Association between chiropractic spinal manipulation for sciatica and opioid-related adverse events: A retrospective cohort study
by
Srinivasan, Roshini
,
Perez, Jaime A.
,
Cupler, Zachary A.
in
Adult
,
Adults
,
Adverse and side effects
2025
Patients receiving chiropractic spinal manipulation (CSM) for spinal pain are less likely to be prescribed opioids, and some evidence suggests that these patients have a lower risk of any type of adverse drug event. We hypothesize that adults receiving CSM for sciatica will have a reduced risk of opioid-related adverse drug events (ORADEs) over a one-year follow-up compared to matched controls not receiving CSM.
We searched a United States (US) claims-based data resource (Diamond Network, TriNetX, Inc.) of more than 216 million patients, yielding data ranging from 2009 to 2024. We included patients aged ≥18 years with sciatica, excluding those post-spine surgery, prior anesthesia, serious pathology, high risk of ORADEs, and an ORADE ≤ 1-year prior. Patients were divided into two cohorts: (1) CSM and (2) usual medical care. We used propensity score matching to control for confounding variables associated with ORADEs. Comparative outcomes were analyzed by calculating risk ratios (RRs) and 95% confidence intervals (CIs) for the incidence of ORADEs and oral opioid prescription between cohorts.
372,471 patients per cohort remained after matching. The incidence of ORADEs over 1-year follow-up was less in the CSM cohort compared to the usual medical care cohort (CSM: 0.09%; usual medical care: 0.30%), yielding an RR of 0.29 (95% CI: 0.25-0.32; P < .00001). CSM patients had a lower risk of receiving an oral opioid prescription (RR of 0.68 [95% CI: 0.68-0.69; P < .00001]).
This study found that adults with sciatica who initially received CSM had a lower risk of an ORADE compared to matched controls not initially receiving CSM, likely explained by a lower probability of opioid prescription. These findings corroborate existing practice guidelines which recommend adding CSM to the management of sciatica when appropriately indicated.
Journal Article
Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial
by
Young, Ian
,
Stanislawski, Thomas
,
Dunning, James R.
in
Adult
,
Cervical Vertebrae
,
Clinical trials
2016
Background
Although commonly utilized interventions, no studies have directly compared the effectiveness of cervical and thoracic manipulation to mobilization and exercise in individuals with cervicogenic headache (CH). The purpose of this study was to compare the effects of manipulation to mobilization and exercise in individuals with CH.
Methods
One hundred and ten participants (
n
= 110) with CH were randomized to receive both cervical and thoracic manipulation (
n
= 58) or mobilization and exercise (
n
= 52). The primary outcome was headache intensity as measured by the Numeric Pain Rating Scale (NPRS). Secondary outcomes included headache frequency, headache duration, disability as measured by the Neck Disability Index (NDI), medication intake, and the Global Rating of Change (GRC). The treatment period was 4 weeks with follow-up assessment at 1 week, 4 weeks, and 3 months after initial treatment session. The primary aim was examined with a 2-way mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization and exercise) as the between subjects variable and time (baseline, 1 week, 4 weeks and 3 months) as the within subjects variable.
Results
The 2X4 ANOVA demonstrated that individuals with CH who received both cervical and thoracic manipulation experienced significantly greater reductions in headache intensity (
p
< 0.001) and disability (
p
< 0.001) than those who received mobilization and exercise at a 3-month follow-up. Individuals in the upper cervical and upper thoracic manipulation group also experienced less frequent headaches and shorter duration of headaches at each follow-up period (
p
< 0.001 for all). Additionally, patient perceived improvement was significantly greater at 1 and 4-week follow-up periods in favor of the manipulation group (
p
< 0.001).
Conclusions
Six to eight sessions of upper cervical and upper thoracic manipulation were shown to be more effective than mobilization and exercise in patients with CH, and the effects were maintained at 3 months.
Trial registration
NCT01580280 April 16, 2012.
Journal Article
Comparative effectiveness of cervical vs thoracic spinal-thrust manipulation for care of cervicogenic headache: A randomized controlled trial
by
Saleh, Ayman K.
,
Ismail, Mohammed Abdelgwad
,
Attallah, Abdehamid A.
in
Analysis
,
Care and treatment
,
Cervical Vertebrae
2024
There is ample evidence supporting the use of different manipulative therapy techniques for Cervicogenic Headache (CgH). However, no technique can be singled as the best available treatment for patients with CgH. Therefore, the objective of the study is to find and compare the clinical effects of cervical spine over thoracic spine manipulation and conventional physiotherapy in patients with CgH.
It is a prospective, randomized controlled study conducted between July 2020 and January 2023 at the University hospital. N = 96 eligible patients with CgH were selected based on selection criteria and they were divided into cervical spine manipulation (CSM; n = 32), thoracic spine manipulation (TSM; n = 32) and conventional physiotherapy (CPT; n = 32) groups, and received the respective treatment for four weeks. Primary (CgH frequency) and secondary CgH pain intensity, CgH disability, neck pain frequency, neck pain intensity, neck pain threshold, cervical flexion rotation test (CFRT), neck disability index (NDI) and quality of life (QoL) scores were measured. The effects of treatment at various intervals were analyzed using a 3 × 4 linear mixed model analysis (LMM), with treatment group (cervical spine manipulation, thoracic spine manipulation, and conventional physiotherapy) and time intervals (baseline, 4 weeks, 8 weeks, and 6 months), and the statistical significance level was set at P < 0.05.
The reports of the CSM, TSM and CPT groups were compared between the groups. Four weeks following treatment CSM group showed more significant changes in primary (CgH frequency) and secondary (CgH pain intensity, CgH disability, neck pain frequency, pain intensity, pain threshold, CFRT, NDI and QoL) than the TSM and CPT groups (p = 0.001). The same gradual improvement was seen in the CSM group when compared to TSM and CPT groups (p = 0.001) in the above variables at 8 weeks and 6 months follow-up.
The reports of the current randomized clinical study found that CSM resulted in significantly better improvements in pain parameters (intensity, frequency and threshold) functional disability and quality of life in patients with CgH than thoracic spine manipulation and conventional physiotherapy.
Clinical trial registration: CTRI/2020/06/026092 trial was registered prospectively on 24/06/2020.
Journal Article
Default mode network and dorsal attentional network connectivity changes as neural markers of spinal manipulative therapy in lumbar disc herniation
by
Lv, Zhi-zhen
,
Wang, Kai-zheng
,
Lv, Li-jiang
in
692/308/2779/109
,
692/698/1671
,
692/700/1421/65
2024
Spinal manipulative therapy (SMT) has been shown to significantly alleviate pain in patients with lumbar disc herniation (LDH), with its effects closely associated with brain function modulation. This study investigates the neural biomarkers linked to pain relief efficacy following a complete SMT treatment cycle in LDH patients. A total of 59 LDH patients were randomized into two groups: SMT treatment (Group 1, n = 28) and sham treatment (ST) (Group 2, n = 31). A matched healthy control group (Group 3, n = 28) was also included. Functional magnetic resonance imaging (fMRI) was performed on LDH patients at two time points (TPs)—before (TP1) and after (TP2) treatment—while healthy controls were scanned once. Clinical assessments were conducted using the Visual Analogue Scale (VAS) and the Japanese Orthopaedic Association (JOA) scale. Post-treatment results indicated significant improvements in both VAS and JOA scores for Group 1, while the improvement was limited to VAS scores for Group 2. Graph properties analysis revealed notable differences in brain network connectivity between LDH patients and healthy controls, particularly between the left precentral gyrus (left PreCG) and left inferior frontal gyrus, opercular part (left IFGoperc). Enhanced functional connectivity (FC) was observed in Group 1, notably between the right angular gyrus (right ANG) and the left middle orbital gyrus (left ORBmid), with right ANG showing a significant positive correlation with clinical scores. This study identifies the sensorimotor network—salience network are significantly activated in chronic pain among LDH patients. The default mode network—dorsal attention network may serve as key neural biomarkers for the efficacy of SMT treatment in alleviating pain in LDH.
Journal Article
Effect of cervical manipulation on vertebral artery and cerebral haemodynamics in patients with chronic neck pain: a crossover randomised controlled trial
by
Wells, Greg
,
Behr, Michael
,
Moser, Nicholas
in
Adult
,
Anticoagulants
,
Arterial Occlusive Diseases - epidemiology
2019
ObjectiveIt is hypothesised that cervical manipulation may increase the risk of cerebrovascular accidents. We aimed to determine whether cervical spine manipulation is associated with changes in vertebral artery and cerebrovascular haemodynamics measured with MRI compared with neutral neck position and maximum neck rotation in patients with chronic neck pain.SettingThe Imaging Research Centre at St. Joseph’s Hospital in Hamilton, Ontario, Canada.ParticipantsTwenty patients were included. The mean age was 32 years (SD ±12.5), mean neck pain duration was 5.3 years (SD ±5.7) and mean neck disability index score was 13/50 (SD ±6.4).InterventionsFollowing baseline measurement of cerebrovascular haemodynamics, we randomised participants to: (1) maximal neck rotation followed by cervical manipulation or (2) cervical manipulation followed by maximal neck rotation. The primary outcome, vertebral arteries and cerebral haemodynamics, was measured after each intervention and was obtained by measuring three-dimensional T1-weighted high-resolution anatomical images, arterial spin labelling and phase-contrast flow encoded MRI. Our secondary outcome was functional connectivity within the default mode network measured with resting state functional MRI.ResultsCompared with neutral neck position, we found a significant change in contralateral blood flow following maximal neck rotation. There was also a significant change in contralateral vertebral artery blood velocity following maximal neck rotation and cervical manipulation. We found no significant changes within the cerebral haemodynamics following cervical manipulation or maximal neck rotation. However, we observed significant increases in functional connectivity in the posterior cerebrum and cerebellum (resting state MRI) after manipulation and maximum rotation.ConclusionOur results are in accordance with previous work, which has shown a decrease in blood flow and velocity in the contralateral vertebral artery with head rotation. This may explain why we also observed a decrease in blood velocity with manipulation because it involves neck rotation. Our work is the first to show that cervical manipulation does not result in brain perfusion changes compared with a neutral neck position or maximal neck rotation. The changes observed were found to not be clinically meaningful and suggests that cervical manipulation may not increase the risk of cerebrovascular events through a haemodynamic mechanism.Trial registration number NCT02667821
Journal Article