Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Fibromyalgia

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05969912
Collaborator
(none)
32
1
2
7.9
4.1

Study Details

Study Description

Brief Summary

To compare the effects of Bowen's and Graston Technique in patients of chronic low back pain for reducing pain, enhancing lumbar range of motion and physical functioning and reducing depression.

Condition or Disease Intervention/Treatment Phase
  • Other: Graston Technique (Instrumented assisted soft tissue mobilization)
  • Other: Bowen's Technique(Soft tissue technique)
N/A

Detailed Description

Fibromyalgia is a chronic disease of idiopathic etiology, which is estimated to affect 2-4% of the population. It causes pain, stiffness, and tenderness in muscles, tendons, and joints, as well as sleep disturbances, fatigue, anxiety, depression, and alterations in intestinal functions. Chronic low back pain is a pain of more than 12 weeks limited to the lower area of the back .The chief complaint of a patient with fibromyalgia is widespread musculoskeletal pain which is bilateral and involves both upper and lower parts of the body. The pain may be localized initially, commonly in the neck and shoulders. The predominant description of the pain is muscle pain, but the patients may complain of joint pain as well .

Grastοn technique is an instrument assisted soft tissue treatment method (ІASTM) derived from the Cyriax1 cross-friction massage. Physіοtherapist strikes stainless steel instrument in a longitudinal dіrectіοn and in circular patterns at the treatment site. Many IASTM instruments including ASTYM, Fascial Abrasion Technique and Graston Technique etc. facilitates the healing process through increased fibroblast proliferation and increased collagen synthesis, maturation, and alignment.

Bowen Therapy is a dynamic fascial and muscle release approach, consisting of gentle cross-fiber movements applied to the fascia, muscles, tendons, muscle insertions, muscle septa, ligaments and viscera. It is named after Tom Bowen, who created a form of bodywork in Geelong, Australia and addresses the body as a whole unit rather than just the presenting symptoms.

The rationale for the use of these techniques is to identify the effects of IASTM and Bowen therapy in chronic low back pain of fibromyalgia and to analyze the additional effects of these techniques by reducing the hyperalgesia and excitability in central nervous system by working on the descending pain modulation system and to identify the most time effective treatment for chronic low back pain in fibromyalgia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Chronic Low Back Pain of Fibromyalgia
Anticipated Study Start Date :
Aug 10, 2023
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Apr 5, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Graston Technique (Instrumented assisted soft tissue mobilization)

Graston technique + Conventional PT

Other: Graston Technique (Instrumented assisted soft tissue mobilization)
They would received Graston technique (Instrumented assisted soft tissue mobilization) as follow: Using lubricant (Vaseline) on the skin then a stainless steel instrument to relax the fascia and muscles. Frequency: 60 reps per min for 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Graston technique (Instrument assisted soft tissue mobilization) Additionally, the would receive Conventional PT : Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks

Active Comparator: Bowen's Technique (Soft tissue technique)

Bowen's technique + Conventional PT

Other: Bowen's Technique(Soft tissue technique)
They would received Bowen's technique (Soft tissue technique) as follow: Bowen moves (15 - 20 times) with 2 mins gap between each set. Frequency: 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Bowen's technique (Soft tissue technique) Additionally, the would receive Conventional PT : Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks

Outcome Measures

Primary Outcome Measures

  1. Fibromyalgia impact questionnaire (FIQ) [3 weeks]

    The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by FM.

Secondary Outcome Measures

  1. Numeric Pain Rating Scale (NPRS) [3 weeks]

    The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

  2. Clinically useful depression outcome scale (CUDOS) [3 weeks]

    There are five categories in the empirically derived range of the depression severity of the CUDOS: scores of 11-20 represent minimal depression; 21-30, mild depression; 31-45, moderate depression; and 46 or higher, severe depression.

  3. Bubble inclinometer [3 weeks]

    It is an instrument that measures the available range of motion at a joint.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age between 30 and 65 years

  • Both Genders

  • Patients with fibromyalgia were included in the study if they fulfilled criteria of the American college of rheumatology for fibromyalgia.

  • Patients having chronic mechanical low back pain of more than three months

Exclusion Criteria:
  • Patients with tumor, infection and major trauma to the spine causing fracture or disruption of spine.

  • Patients with cauda equina syndrome

  • Any neurological disorder

  • Any previous spinal fusion surgery or spinal cord stimulation.

  • Pregnant females

Contacts and Locations

Locations

Site City State Country Postal Code
1 Daultala centre of CBR/CBID Daultala centre of CBR/CBID and (ALP Hospital Rawalpindi). Gujar Khān Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: KINZA ANWAR, MS-OMPT, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05969912
Other Study ID Numbers:
  • S22C08G30012 ANUM SHAHEEN
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023