Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT03270631
• Date of registration: 29/08/2017
• Prospective Registration: No
• Primary sponsor: Oulu University Hospital
• Public title: Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
• Scientific title: Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
• Date of first enrolment: August 28, 2017
• Target sample size: 250
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT03270631
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Jani Takatalo, PhD
• Affiliation: Oulu University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Chronic non-operatively treated low back pain or pain after the low back operation.
Participation in multidisciplinary rehabilitation at University Hospital of Oulu.

Exclusion Criteria:

- Specific low back pain cause and earlier fascial manipulation treatment given.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Low Back Pain, Recurrent

Low Back Pain

Intervention(s)

Other: MCE and sham-FM

Other: FM and sham-MCE

Other: Sham-MCE and sham-FM

Other: FM and MCE

Primary Outcome(s)

Change in Patient Specific Functional Scale (PSFS) [Time Frame: Baseline, 3, 6 and 12 months]

Secondary Outcome(s)

Change in Balance measured with computer [Time Frame: Change from baseline at 3 month]

Change in Two-point discrimination [Time Frame: Change from baseline at 3 month]

Change in Oswestry [Time Frame: Baseline, 3, 6 and 12 months]

Change in Start back [Time Frame: Baseline, 3, 6 and 12 months]

Change in Visual analogue Scale [Time Frame: Baseline, 3, 6 and 12 months]

Change in PROMIS [Time Frame: Baseline, 3, 6 and 12 months]

Change in Linton Örebro [Time Frame: Baseline, 3, 6 and 12 months]

Change in Movement control tests [Time Frame: Change from baseline at 3 month]

Change in Ultrasound of the fascia [Time Frame: Change from baseline at 3 month]

Change in Lef-right discrimination [Time Frame: Change from baseline at 3 month]

Change in Spinal mouse [Time Frame: Change from baseline at 3 month]

Change in Mobility of the hips [Time Frame: Change from baseline at 3 month]

Change in Tampa Scale of Kinesiophobia [Time Frame: Baseline, 3, 6 and 12 months]

Secondary ID(s)

FM&KCStudy

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Faskia-Markus, Oulu

Fysios Kastelli, Oulu

Loisto Terveys, Oulu