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Enrolling by Invitation

NCT Number: NCT03270631

Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in at that point as well. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Oulu

Oulu, 90029, Finland

About this study

Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the measurements are blinded to each other. Physical therapist who is performing measurements is also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FM and MCE

Other

Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.

FM and sham-MCE

Other

Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.

MCE and sham-FM

Other

Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized.

Sham-MCE and sham-FM

Other

Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.

Primary outcomes

  1. Change in Patient Specific Functional Scale (PSFS)

    Time frame: Baseline, 3, 6 and 12 months

    Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.

Secondary outcomes

  1. Change in Oswestry

    Time frame: Baseline, 3, 6 and 12 months

    Disability index

  2. Change in PROMIS

    Time frame: Baseline, 3, 6 and 12 months

    Quality of life

  3. Change in Tampa Scale of Kinesiophobia

    Time frame: Baseline, 3, 6 and 12 months

    Fear of movement

  4. Change in Visual analogue Scale

    Time frame: Baseline, 3, 6 and 12 months

    Pain scale

  5. Change in Linton Örebro

    Time frame: Baseline, 3, 6 and 12 months

    Psychosocial risk factor

  6. Change in Start back

    Time frame: Baseline, 3, 6 and 12 months

    Screening tool of the psychosocial risk factors

  7. Change in Movement control tests

    Time frame: Change from baseline at 3 month

    Clinical tests for LBP

  8. Change in Spinal mouse

    Time frame: Change from baseline at 3 month

    Mobility of the spine

  9. Change in Balance measured with computer

    Time frame: Change from baseline at 3 month

    Power plate

  10. Change in Mobility of the hips

    Time frame: Change from baseline at 3 month

    Hip ROM

  11. Change in Two-point discrimination

    Time frame: Change from baseline at 3 month

    How far apart subject is able to feel two distinctive point of touch

  12. Change in Lef-right discrimination

    Time frame: Change from baseline at 3 month

    How subject is able to understand right and left of the back

  13. Change in Ultrasound of the fascia

    Time frame: Change from baseline at 3 month

    Several fascial structures are measured

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Collaborators

  • Faskia-Markus, Oulu
  • Fysios Kastelli, Oulu
  • Loisto Terveys, Oulu

Registry information

Official study title

Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2017
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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