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

NCT ID: NCT05969912

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-04-05

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.

Conditions

Fibromyalgia; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Graston Technique (Instrumented assisted soft tissue mobilization)

Graston technique + Conventional PT

Group Type: ACTIVE_COMPARATOR

Graston Technique (Instrumented assisted soft tissue mobilization)

Intervention Type: OTHER

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

Bowen's Technique (Soft tissue technique)

Bowen's technique + Conventional PT

Group Type: ACTIVE_COMPARATOR

Bowen's Technique(Soft tissue technique)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KINZA ANWAR, MS-OMPT

Role: PRINCIPAL_INVESTIGATOR

RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

Locations

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

Gujar Khān, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

KINZA ANWAR, MS-OMPT

Role: CONTACT

kinza.anwar@riphah.edu.pk

+92-3239735427

Facility Contacts

KINZA ANWAR, MS-OMPT

Role: primary

kinza.anwar@riphah.edu.pk

+92-3239735427

ANUM SHAHEEN

Role: backup

Other Identifiers

REC/01650 Anum Shaheen

Identifier Type: -

Identifier Source: org_study_id