Condition category
Musculoskeletal Diseases
Date applied
24/07/2013
Date assigned
06/09/2013
Last edited
17/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic lower back pain (CLBP) is a significant public health problem with significant associated costs. There are currently over 200 different treatments available for CLBP. Spinal manipulation (SMT) is commonly used for CLBP. However, there is a need to identify those patients who are most likely to respond to SMT. The clinical prediction rule for SMT (CPRSMT) is to predict responsiveness to SMT in patients with acute (severe) lower back pain; however, there is a need to validate this rule in a chronic (long-term) lower back pain population. The aim of this study was to find out how well the CPRSMT predicted responsiveness to SMT compared to active exercise therapy (AET).

Who can participate?
Men and women over the age of 18 with a history of back pain for more than three months can participate in the study.

What does the study involve?
Patients came to a screening visit to find out their status on the CPRSMT and based on their status, they were then randomly allocated to either SMT or AET. Patients underwent two treatments per week for four weeks of SMT or AET.

What are the possible benefits and risks of participating?
Patients undergoing care may experience improvement in their CLBP. Patients undergoing either therapy may experience soreness or worsening of their CLBP.

Where is the study run from?
The study took place in Rochester (NY, USA) in Veteran Affairs clinics or outpatient chiropractic and physical therapy clinics.

When is study starting and how long is it expected to run for?
The study began recruiting participants in 2006 and was closed to enrolment in 2009.

Who is funding the study?
Department of Health and Human Services Health Resources and Services Administration (USA).

Who is the main contact?
Paul Dougherty, DC
Paul.Dougherty@va.gov

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Dougherty

ORCID ID

Contact details

919 Westfall Road
Building B
Suite #120
Rochester
14618
United States of America
585-463-2673
paul.dougherty@va.gov

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HRSA Grant #: 4 R18HP07641-03-03

Study information

Scientific title

Evaluation of the clinical prediction rule for spinal manipulation in chronic lower back pain: a prospective randomized clinical trial

Acronym

Study hypothesis

Objective 1. To test the impact of a patient individual difference, i.e., treatment responsiveness, as defined by the Childs et al, validated Clinical Prediction Rule as a moderator of the effectiveness of Spinal Manipulative Therapy (SMT) and Active Exercise Therapy (AET) program, utilizing Visual analogue scale, Oswestry disability index and bodily pain and physical functioning subscales of the SF-36 as outcomes.
Hypothesis 1. Outcomes, immediately post, 3 months post and 6 months post intervention, will be significantly more positive in the SMT conditions compared to the AET conditions (i.e., a significant main effect of treatment).
Hypothesis 2. Outcomes, immediately post, 3 months post and 6 months post intervention, will be significantly more positive in patients in the Positive Clinical Prediction Rule group compared to patients in the Negative Clinical Prediction Rule group (i.e., a significant main effect of patient group).
Hypothesis 3. Outcomes, immediately post, 3 months post and 6 months post intervention, will be most positive when patients in the Positive Clinical Prediction Rule group are treated by SMT compared to patients who are in the Negative Clinical Prediction Rule group and Positive Clinical Prediction Rule group patients treated by AET (i.e., a significant treatment by patient group interaction).

Objective 2. To collect prospective data on potential negative outcomes associated with SMT and AET by convening a data and safety board that will monitor negative treatment outcomes. This will be done in a single blinded prospective fashion to enable direct statistical comparison between the chiropractic treatment and active physical therapy groups.
Hypothesis 1: The incidence of adverse events between the SMT and APT group will show no statistical difference.
Hypothesis 2: Side effect data in the SMT and APT groups will be similar to reported side effects, based on historical review of the literature.

Objective 3. To compare satisfaction with routine chiropractic management versus active exercise therapy in a population with chronic lower back pain using a validated patient satisfaction questionnaire.
Hypothesis: Patients receiving routine SMT will be more satisfied with their care compared to those patients AET.

Ethics approval

1. Syracuse VA Institutional Review Board (IRB): MIRB 00367
2. New York Chiropractic College IRB: 07-01

Study design

Randomized Trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic Lower Back pain

Intervention

Interventions were performed two times per week for four weeks (total of eight treatments).
Spinal Manipulative Therapy: SMT included high velocity low amplitude spinal manipulation, flexion distraction therapy, mobilization, and advise on heat/ice all of which are commonly performed by chiropractors. The practitioner was allowed to give the patient one of two stretches to do at home, either “cat/camel stretch” or “knee to chest stretch.”
Active Exercise Therapy: AET included directional preference exercises, lumbar stabilization, general flexibility, and specific training exercises. The exercises were divided into different categories, dynamic lumbar stabilization, directional preference, flexibility and specific training exercises.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain: Visual Analogue Scale
2. Disability: modified Oswestry Disability Index
Outcome measures were administered at: baseline, immediately post intervention (4 weeks post baseline), 12 weeks post baseline and 24 weeks post baseline.

Secondary outcome measures

1. Bodily Pain and Physical Functional subscales of the SF-36
2. Patient Satisfaction
3. Patient Expectation
Outcome measures were administered at: baseline, immediately post intervention (4 weeks post baseline), 12 weeks post baseline and 24 weeks post baseline.

Overall trial start date

01/06/2006

Overall trial end date

18/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. LBP for 12 weeks prior to enrollment
2. Pain upon deep palpation of the lumbar erector spinae
3. LBP from L1 to sacroiliac joint inclusive
4. Live within 50 miles of Rochester, NY
5. Have a baseline > 30mm on the Visual Analogue Scale (VAS) and > 20% on the Oswestry Disability Index (ODI)
6. Subjects had to be willing to undergo no new or different treatment during the study intervention and follow up period, although they were allowed to continue any medications.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

192

Participant exclusion criteria

1. Radiographic or clinical evidence of cauda equina syndrome, spinal neoplasia or metastatic disease
2. Destructive joint pathology such as rheumatoid arthritis
3. Bowel/bladder dysfunction associated with the LBP
4. Peripheral neuropathy or progressive lumbosacral radiculopathy
5. Progressive myelopathy or neurogenic claudication
6. Spinal surgery within the past six months.
7. Subjects were excluded if they had undergone a course of SMT or supervised AET within the six months prior to enrollment into the study
8. If they could not perform an exercise program based on a New York Heart Association Classification of grade III or IV

Recruitment start date

01/06/2006

Recruitment end date

18/12/2009

Locations

Countries of recruitment

United States of America

Trial participating centre

919 Westfall Road
Rochester
14618
United States of America

Sponsor information

Organisation

U.S. Department of Health and Human Services (USA)

Sponsor details

c/o Catherine Rupinta
HRSA/BHPr/DMD
5600 Fishers Lane
Rockville
MD
20857-0001
United States of America
301-443-1070
crupinta@hrsa.gov

Sponsor type

Government

Website

http://bhpr.hrsa.gov/grants/geriatricsalliedhealth/cdp.html

Funders

Funder type

Government

Funder name

This project was funded by Health Resources and Services Administration (HRSA), USA. The grant was administered through the New York Chiropractic College (USA).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25426289

Publication citations

Additional files

Editorial Notes