NCT01322399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

2.7 years

First QC Date

March 23, 2011

Last Update Submit

December 9, 2013

Conditions

Back Pain Lower Back Chronic

Keywords

low back painchronic painmanual therapyStructural Integration

Outcome Measures

Primary Outcomes (1)

  • Patient rated visual analogue scale (0-10) disturbingness of low back related pain retrospective for one weeks.

    20 weeks

Secondary Outcomes (1)

  • Total score on the Roland Disability Scale

    20 weeks

Study Arms (2)

Structural Integration plus usual care

EXPERIMENTAL

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 IntegrationProcedure: Usual care

Usual care

ACTIVE COMPARATOR

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

Interventions

Structural IntegrationPROCEDURE

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.

Also known as: Rolfing, a registered service mark of the Rolf Institute
Structural Integration plus usual care
Usual carePROCEDURE

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

Also known as: Standard care
Structural Integration plus usual careUsual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)
  • 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
  • Fibromyalgia
  • Severe or progressive neurological deficits, including neuromotor impairment
  • Any hypercoagulation condition
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Related Publications (1)

  • Jacobson EE, Meleger AL, Bonato P, Wayne PM, Langevin HM, Kaptchuk TJ, Davis RB. Structural integration as an adjunct to outpatient rehabilitation for chronic nonspecific low back pain: a randomized pilot clinical trial. Evid Based Complement Alternat Med. 2015;2015:813418. doi: 10.1155/2015/813418. Epub 2015 Apr 7.

    PMID: 25945112DERIVED

MeSH Terms

Conditions

Low Back PainChronic Pain

Interventions

Musculoskeletal ManipulationsStandard of Care

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Paolo Bonato, PhD

    Spaulding Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Motion Analysis Lab

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

December 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

US(1)