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

Primary Purpose

Fibromyalgia, Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Graston Technique (Instrumented assisted soft tissue mobilization)
Bowen's Technique(Soft tissue technique)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Bowen technique, Instrument assisted soft tissue mobilization

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daultala centre of CBR/CBID Daultala centre of CBR/CBID and (ALP Hospital Rawalpindi).Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Graston Technique (Instrumented assisted soft tissue mobilization)

Bowen's Technique (Soft tissue technique)

Arm Description

Graston technique + Conventional PT

Bowen's technique + Conventional PT

Outcomes

Primary Outcome Measures

Fibromyalgia impact questionnaire (FIQ)
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

Numeric Pain Rating Scale (NPRS)
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.
Clinically useful depression outcome scale (CUDOS)
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.
Bubble inclinometer
It is an instrument that measures the available range of motion at a joint.

Full Information

First Posted
July 23, 2023
Last Updated
August 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05969912
Brief Title
Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Fibromyalgia
Official Title
Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Chronic Low Back Pain of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
April 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Low Back Pain
Keywords
Bowen technique, Instrument assisted soft tissue mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Graston Technique (Instrumented assisted soft tissue mobilization)
Arm Type
Active Comparator
Arm Description
Graston technique + Conventional PT
Arm Title
Bowen's Technique (Soft tissue technique)
Arm Type
Active Comparator
Arm Description
Bowen's technique + Conventional PT
Intervention Type
Other
Intervention Name(s)
Graston Technique (Instrumented assisted soft tissue mobilization)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Bowen's Technique(Soft tissue technique)
Intervention Description
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
Primary Outcome Measure Information:
Title
Fibromyalgia impact questionnaire (FIQ)
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
3 weeks
Title
Clinically useful depression outcome scale (CUDOS)
Description
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.
Time Frame
3 weeks
Title
Bubble inclinometer
Description
It is an instrument that measures the available range of motion at a joint.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KINZA ANWAR, MS-OMPT
Phone
+92-3239735427
Email
kinza.anwar@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KINZA ANWAR, MS-OMPT
Organizational Affiliation
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daultala centre of CBR/CBID Daultala centre of CBR/CBID and (ALP Hospital Rawalpindi).
City
Gujar Khān
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KINZA ANWAR, MS-OMPT
Phone
+92-3239735427
Email
kinza.anwar@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
ANUM SHAHEEN
First Name & Middle Initial & Last Name & Degree
ANUM SHAHEEN, MS-OMPT*

12. IPD Sharing Statement

Plan to Share IPD
No

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

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