Structural Integration for Chronic Low Back Pain - Full Text View

Purpose

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.

Condition	Intervention
Back Pain Lower Back Chronic	Procedure: Structural Integration Procedure: Usual care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Structural Integration for Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Rehabilitation

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:

Patient rated visual analogue scale (0-10) disturbingness of low back related pain retrospective for one weeks. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total score on the Roland Disability Scale [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2010
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Structural Integration plus usual care Each subject in this arm will receive ten Structural Integration treatments at intervals of between one and three weeks, and will also receive usual care for chronic low back pain as standard practice at Spaulding Medford Rehabilitation Clinic, which may include pain medication, exercise and physical therapy. Usual care will be provided on average twice weekly for between 3 and 7 weeks, at the discretion of the clinic's medical director	Procedure: Structural Integration Structural Integration (SI) is an alternative method of manual therapy and somato-sensory training that purports to improve biomechanical functioning of the body as a whole rather than to focus on the treatment of specific symptoms. SI therapists employ both manipulation and somatosensory education. SI is delivered in a series of ten treatments, referred to as "the Ten Series," each of approximately one hour in duration. The Ten Series protocol includes manipulation of all major joints and anatomical segments. Each of the ten sessions aims to achieve a different set of biomechanical changes, which are regarded as contributing to the progressive approximation of specific ideals of posture and movement. Other Name: Rolfing, a registered service mark of the Rolf Institute Procedure: Usual care Usual care in this study consists of the treatment regimen provided for chronic low back pain at Spaulding Medford Rehabilitation clinic, which may include pain medication, exercise and physical therapy. Frequency of treatment averages twice weekly, duration ranges from 3 to 7 weeks Other Name: Standard care
Active Comparator: Usual care Each subject in this arm will receive care for chronic low back pain as standard practice at Spaulding Medford Rehabilitation Clinic, which may include pain medication, exercise and physical therapy. Usual care will be provided on average twice weekly for between 3 and 7 weeks, at the discretion of the clinic's medical director	Procedure: Usual care Usual care in this study consists of the treatment regimen provided for chronic low back pain at Spaulding Medford Rehabilitation clinic, which may include pain medication, exercise and physical therapy. Frequency of treatment averages twice weekly, duration ranges from 3 to 7 weeks Other Name: Standard care

Arms

Assigned Interventions

Experimental: Structural Integration plus usual care

Each subject in this arm will receive ten Structural Integration treatments at intervals of between one and three weeks, and will also receive usual care for chronic low back pain as standard practice at Spaulding Medford Rehabilitation Clinic, which may include pain medication, exercise and physical therapy. Usual care will be provided on average twice weekly for between 3 and 7 weeks, at the discretion of the clinic's medical director

Procedure: Structural Integration

Structural Integration (SI) is an alternative method of manual therapy and somato-sensory training that purports to improve biomechanical functioning of the body as a whole rather than to focus on the treatment of specific symptoms. SI therapists employ both manipulation and somatosensory education. SI is delivered in a series of ten treatments, referred to as "the Ten Series," each of approximately one hour in duration. The Ten Series protocol includes manipulation of all major joints and anatomical segments. Each of the ten sessions aims to achieve a different set of biomechanical changes, which are regarded as contributing to the progressive approximation of specific ideals of posture and movement.

Other Name: Rolfing, a registered service mark of the Rolf Institute

Procedure: Usual care

Usual care in this study consists of the treatment regimen provided for chronic low back pain at Spaulding Medford Rehabilitation clinic, which may include pain medication, exercise and physical therapy. Frequency of treatment averages twice weekly, duration ranges from 3 to 7 weeks

Other Name: Standard care

Active Comparator: Usual care

Each subject in this arm will receive care for chronic low back pain as standard practice at Spaulding Medford Rehabilitation Clinic, which may include pain medication, exercise and physical therapy. Usual care will be provided on average twice weekly for between 3 and 7 weeks, at the discretion of the clinic's medical director

Procedure: Usual care

Usual care in this study consists of the treatment regimen provided for chronic low back pain at Spaulding Medford Rehabilitation clinic, which may include pain medication, exercise and physical therapy. Frequency of treatment averages twice weekly, duration ranges from 3 to 7 weeks

Other Name: Standard care

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Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
1. Balance problems due to vestibular or other neurological impairments
2. Osteoporosis (osteopenia is not exclusionary)
3. Fibromyalgia
4. Severe or progressive neurological deficits, including neuromotor impairment
5. Any hypercoagulation condition
6. Eczema, skin infections, deep vein thrombosis
7. Burns or other acute trauma including unhealed bone fractures or open wounds.
8. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322399

Locations

United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Paolo Bonato, PhD

Spaulding Rehabilitation Hospital

More Information

No publications provided

Responsible Party:	Paolo Bonato, Director, Motion Analysis Lab, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:	NCT01322399 History of Changes
Other Study ID Numbers:	2010-P-000014; SRH, K01AT004916
Study First Received:	March 23, 2011
Last Updated:	March 21, 2013
Health Authority:	United States: Federal Government

Keywords provided by Spaulding Rehabilitation Hospital:

low back pain
chronic pain
manual therapy
Structural Integration

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013