Structural Integration for Chronic Low Back Pain
Completed · Not applicable
Conditions studied: Back Pain Lower Back Chronic
In brief
The primary purpose of study is the collection of feasibility data for a larger trial of Structural Integration (SI)(an alternative manual therapy) for chronic low back pain. The secondary purpose is the collection of preliminary data on 1) the therapeutic effect of SI plus usual care versus usual care alone - the hypothesis being the the effect size will be significantly greater in the SI plus usual care arm; and on 2) specific hypothesized mechanisms of that hypothesized therapeutic effect: a) improvements in cognitive behavioral factors; b) improvements in standing balance and gait, and c) improvements in selected blood biomarkers.
Key facts
- Study ID
- NCT01322399
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 46
- Starts
- 2010-12-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2013-12-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic low back pain patient-rated >=3 on a VAS (0-10) with retrospective duration of at least 6 months
- Low back pain attributed to mechanical as opposed to infectious, neoplastic or inflammatory causes
- Age 18-65
- English speaking
- Male or female
- Mental capacity sufficient to provide informed consent
- Able to commit to up to 27 study meetings over a period of 5 months.
You may not qualify if…
- Impairment of hearing, speech, vision, mobility or English fluency sufficient to interfere with participation in the study
- Current or anticipated receipt of payments from Workmen's Compensation or other insurance for disability attributed to low back pain.
- Reports any prior treatment with Structural Integration (Rolf or other varieties, including "structural massage")
- Plans to initiate additional treatment for back pain during the period of the study other than usual rehabilitation care provided at Spaulding Medford clinic, particularly massage or other manual therapy (e.g. chiropractic, osteopathic)
- Unresolved musculoskeletal pathology of the lower limbs
- Pregnancy
- Clinical judgment by Spaulding Medford medical director that the candidate will require either surgery or epidural analgesia within the next five months.
- Alcohol of substance abuse
- Any implanted medical device (e.g. cardio-pacemaker, shunts)
- Prior discectomy or implantation of rods, screws or plates (bulging disc without radicular pain is not exclusionary; hip or shoulder replacement is not exclusionary)
- Current medication with coumadin or prednisone, chronic use of steroid medications, daily use of narcotic analgesics.
- Current diagnosis with any of the following
- Balance problems due to vestibular or other neurological impairments
- Osteoporosis (osteopenia is not exclusionary)
- Fibromyalgia
- Severe or progressive neurological deficits, including neuromotor impairment
- Any hypercoagulation condition
- Eczema, skin infections, deep vein thrombosis
- Burns or other acute trauma including unhealed bone fractures or open wounds.
- Psychiatric illness not well controlled, or current episode of exacerbated major depressive disorder.
- Any other major medical condition that has not been stabilized, or that would impair the patient's ability to complete the activities required by the study
- Body Mass Index >= 40
Where it is running
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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