FibromyalgiaNCT05969912
Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Fibromyalgia
A study testing Graston Technique (Instrumented assisted soft tissue mobilization) and Bowen's Technique(Soft tissue technique) in people with Fibromyalgia and Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Fibromyalgia, Low Back Pain
- What is being tested?
- Graston Technique (Instrumented assisted soft tissue mobilization) and Bowen's Technique(Soft tissue technique)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2023to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Daultala centre of CBR/CBID Daultala centre of CBR/CBID and (ALP Hospital Rawalpindi).
Gujar Khān
KINZA ANWAR, MS-OMPT, +92-3239735427, kinza.anwar@riphah.edu.pk
ANUM SHAHEEN
About this study
Official title: 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.
Read the 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
- Being tested
- Graston Technique (Instrumented assisted soft tissue mobilization), Bowen's Technique(Soft tissue technique)
- Keywords
- Bowen technique, Instrument assisted soft tissue mobilization
- Medical subject headings
- Fibromyalgia, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graston Technique (Instrumented assisted soft tissue mobilization)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)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
| Study group | Role | What they receive |
|---|---|---|
| Graston Technique (Instrumented assisted soft tissue mobilization) | Active comparator | Graston technique + Conventional PT Receives: Other: Graston Technique (Instrumented assisted soft tissue mobilization) |
| Bowen's Technique (Soft tissue technique) | Active comparator | Bowen's technique + Conventional PT Receives: Other: Bowen's Technique(Soft tissue technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 3 weeks
Bubble inclinometer
It is an instrument that measures the available range of motion at a joint.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start30 Aug 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion5 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KINZA ANWAR, MS-OMPT, Principal investigator, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969912
- Sponsor's protocol ID
- REC/01650 Anum Shaheen
- Status last verified
- Aug 2023
- First submitted
- 23 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Chronic Low Back Pain of Fibromyalgia
- ClinicalTrials.gov ID
- NCT05969912
- Acronym / sponsor ID
- REC/01650 Anum Shaheen
- Conditions
- Fibromyalgia, Low Back Pain
- Keywords
- Bowen technique, Instrument assisted soft tissue mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 5 Apr 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graston Technique (Instrumented assisted soft tissue mobilization) | Active comparator | Other: Graston Technique (Instrumented assisted soft tissue mobilization)Graston technique + Conventional PT |
| Bowen's Technique (Soft tissue technique) | Active comparator | Other: Bowen's Technique(Soft tissue technique)Bowen's technique + Conventional PT |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Graston Technique (Instrumented assisted soft tissue mobilization) |
| 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 | Other | Bowen's Technique (Soft tissue technique) |
Primary outcome
Fibromyalgia impact questionnaire (FIQ)
Time frame: 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.
3 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: 3 weeks
Clinically useful depression outcome scale (CUDOS)
Time frame: 3 weeks
Bubble inclinometer
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KINZA ANWAR, MS-OMPT principal investigator
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graston Technique (Instrumented assisted soft tissue mobilization) and Bowen's Technique(Soft tissue technique) in people with Fibromyalgia and Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KINZA ANWAR, MS-OMPT (+92-3239735427, kinza.anwar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia impact questionnaire (FIQ) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.