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

Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Chronic Low Back Pain of Fibromyalgia

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Fibromyalgia
• Intervention / Treatment: Other: Graston Technique (Instrumented assisted soft tissue mobilization); Other: Bowen's Technique(Soft tissue technique)

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: KINZA ANWAR, MS-OMPT; Phone Number: +92-3239735427; Email: kinza.anwar@riphah.edu.pk

Study Locations

• Pakistan
  • Gujar Khān, Pakistan
    • Recruiting
    • Daultala centre of CBR/CBID Daultala centre of CBR/CBID and (ALP Hospital Rawalpindi).
    • Contact: KINZA ANWAR, MS-OMPT; Phone Number: +92-3239735427; Email: kinza.anwar@riphah.edu.pk
    • Contact: ANUM SHAHEEN
    • Sub-Investigator: ANUM SHAHEEN, MS-OMPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks
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.	3 weeks
Bubble inclinometer	It is an instrument that measures the available range of motion at a joint.	3 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: KINZA ANWAR, MS-OMPT, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): April 5, 2024

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Bowen technique; Instrument assisted soft tissue mobilization
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Back Pain; Low Back Pain; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: REC/01650 Anum Shaheen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No