FibromyalgiaNCT04554784
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
A study testing Conventional and Bowen in people with Fibromyalgia, run by Alice Ho Miu Ling Nethersole Hospital at 1 site in Hong Kong.
Trial summary
The aim of this prospective, randomized study is to explore the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. In Hong Kong, Bowen Therapy is a non-invasive technique and one of the treatment modalities adopted by Occupational Therapists. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Conventional and Bowen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Sep 2020to 6 Sep 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Widespread pain index (WPI) ≧7 and symptom severity (SS) scale score ≧5 or WPI between 3 and 6 with SS scale score ≧9. The WPI includes evaluation of tender points at 19 regions. Tender point count (TPC) is examined by application of approximately 4 kg/cm2 pressure with the tip of the thumb on those regions.
- Symptoms have been present at a similar level for at least 3 months.
- Patient does not have any disorder that would otherwise explain the pain
- Agrees to participate in the study and agree to discontinue other alternatives treatments except in conditions otherwise approved by the investigators.
Who cannot join
- Patient refusal
- pregnancy
- assessed to be contraindicated to participate by pain specialists due to the presence of other co-morbidities or conditions
- underlining disease that affect mobility of upper limb and lower limb
- known severe psychiatric illness
- known malignancy, skin disease, infectious disease, severe cardiovascular disease, patients taking anti-coagulants
- enrolled in other studies
- refuse to temporarily discontinue concurrent treatment or intervention as pain management during the study period e.g. alternative medicine, physiotherapy, chiropractor
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Pain Management Centre (NTEC); PWH/ AHNH
Shatin, New Territories
Pik Yu Chen, RN, BSc, MSc, 55696031, pro910@cuhk.edu.hk
About this study
Official title: A Prospective Randomized Control Trial on the Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
The aim of this prospective, randomized study is to explore the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. In Hong Kong, Bowen Therapy is a non-invasive technique and one of the treatment modalities adopted by Occupational Therapists. Bowen Therapy uses specific sequences of gentle cross-fibre moves over muscles, tendons, ligaments, and fascia to stimulate or improve the flow of blood and lymph, and thus activate the body's healing mechanisms that enhances tissue repair. As a result, it can lessen pain and tension, restore more optimal body function, and subsequently alleviate emotional and psychological stress associated with the pain. Bowen Therapy is widely recognized and utilized worldwide for acute and chronic health conditions from new-born to the elderly, both mobilized and bed-ridden patients with no documented evidence to show it has caused any harm or adverse effects.
There are two study groups in this study and patients will be randomized and allocated to either one. One group (Control group) will continue receiving conventional treatment; while another group (Bowen group) will receive 8 sessions of Bowen therapy. The investigators hypothesize that Bowen Therapy is superior to the conventional pain treatment for patients with fibromyalgia.
Read the detailed description
This study is going to look at the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. 80 patients with fibromyalgia attending pain management clinic will be recruited at Alice Ho Miu Ling Nethersole Hospital after informed consent. They will be randomized into either group (control group or Bowen group). Control group will continue receiving conventional treatment such as follow-ups by pain specialists, taking analgesia, physiotherapy. Bowen group will need to attend 8 sessions of therapy. All subjects will be evaluated at 12th week and 24th week after signing the consent.
- Conditions
- Fibromyalgia
- Being tested
- Conventional, Bowen
- Keywords
- Bowen Therapy, conventional pain management
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalOther
Patients' condition will be continue managed by pain specialists with regular follow-ups and continue patients' active concurrent pain treatment such as taking analgesics, physiotherapy, massage, chiropractor.
BowenProcedure or surgery
Patients will be referred to Occupational therapist for Bowen Therapy. There will be a week washout period before the start of Bowen Therapy. During a week washout period and study period, patients can continue taking analgesia, but advised to stop the concurrent treatments which can affect the deep tissue such as massage, physiotherapy, and chiropractic to minimize the counteracting effect on the Bowen's action.
During a Bowen Therapy session, patients will lie relaxed on the examination couch wearing loosely fitting clothing or only the affected area being exposed. The therapist applies a series of gentle movements across the body. The gentle movements focus on a body of muscle, tendon or nerve and release tension through the nerve within the area. Each session will last for 30 minutes to an hour. After each session, the next appointment will be given to patients. The first four sessions will be scheduled on weekly basis, and the remaining four on biweekly session.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Conventional pain treatment. Receives: Other: Conventional |
| Bowen | Active comparator | Patients will be referred to Occupational Therapist for Bowen therapy. Receives: Procedure: Bowen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Score
The pain score in Numeric Rating Scale (0-10) for both groups of patients, which 0= no pain to 10=worst pain.
Measured: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
Secondary outcomes (6)
Change of Endurance strength test of lower extremities
For the test of lower extremities, study subjects will be asked to sit comfortably on a chair with the back straight. The arms are extended parallel to the trunk with the elbow and shoulder in 0° of flexion/extension, and each hand hold a dumbbell weighing 2.5kg. On receiving a signal from a metronome, subjects rise to a full standing position (body erect and straight), and at the next signal of the metronome, they return back to the initial seated position, maintaining arm extension. The pace of the metronome is 60 beats per minute and 90° of movement per second. The score is measured as the total number of stands executed correctly until the participant cannot keep up with the pace of the metronome.
Measured: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
Change of Endurance strength test of upper extremities
For the test of upper extremities, you sit on the same chair, leaning back completely, extending the dominant arm parallel to the trunk with the elbow and shoulder in 0° of flexion/extension, and holding a dumbbell weighing 2.5kg. At the signal of the metronome, you bend the weight through a full range of elbow flexion. At the next signal of the metronome, you return to the initial position, keeping the back straight. The pace of the metronome is 60 beats per minute and 120° of movement per second. The score is measured as the total number of curls executed correctly until you cannot keep up with the pace of the metronome. This test is repeated on the other arm. The tests are approximately 5 to 10 minutes per patient.
Measured: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
Change of Brief pain inventory-Short Form (BPI)
BPI measures clinical pain. It allows cases to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. A scale of 0-10, 0=no interference and 10= completely interference.
Measured: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Change of Hospital anxiety and depression scale (HADS)
HADS determines the level of anxiety and depression that subjects are experiencing during the study period. It consists of 14 items scale of which 7 items relate to anxiety and 7 relate to depression. Each item is scored from 0-3 (0=normal; 3=worst) and a cut off point of 8/21 for either anxiety or depression.
Measured: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Change of 36-item Short form Survey (SF-36)
SF-36 measures health and mental status, which consists of 8 scaled scores. The 8 scaled scores are: vitality, physical functioning, bodily pain, general health perceptions, physical health functioning, emotional role functioning, social role functioning, \& mental health. Each scale is directly transformed into a 0-100 scale [0=disability to 100=no disability].
Measured: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Jenkins Sleep Evaluation Questionnaire (JSEQ) for sleep
JSEQ evaluate the impact of therapies upon sleep problems. It is a 4 items questionnaire with a score of 0-5 for each item. A total score of 0= no sleep disturbance to 20 = highest sleep disturbance.
Measured: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start6 Sep 2020
- Primary completion6 Dec 2022 (estimated)
- Study completion6 Sep 2023 (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.
- 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
- Model description
- Patients will be randomly allocated to receive either conventional treatment or Bowen Therapy, following the computer-generated sequence (1= Control, 2= Bowen Therapy). The randomization sequence will be prepared by a research assistant, who will not take part in the study. The randomization sequence will be placed in a brown, and sealed envelopes: Group 1 (n= 40): Control (conventional treatment); and Group 2 (n= 40): Bowen Therapy.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alice Ho Miu Ling Nethersole Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Ms Pik Yu CHEN, Alice Ho Miu Ling Nethersole Hospital
- Investigators
- Pik Yu Chen, RN, BSc, MSc, Principal investigator, Pain Nurse (Registered Nurse)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554784
- Sponsor's protocol ID
- Bowen (fibro) 2020.357
- Status last verified
- Feb 2022
- First submitted
- 11 Sep 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Control Trial on the Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04554784
- Acronym / sponsor ID
- Bowen (fibro) 2020.357
- Conditions
- Fibromyalgia
- Keywords
- Bowen Therapy, conventional pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alice Ho Miu Ling Nethersole HospitalUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 6 Sep 2020 (actual)
- Primary completion
- 6 Dec 2022 (estimated)
- Study completion
- 6 Sep 2023 (estimated)
- First posted
- 18 Sep 2020 (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.
The aim of this prospective, randomized study is to explore the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. In Hong Kong, Bowen Therapy is a non-invasive technique and one of the treatment modalities adopted by Occupational Therapists. Bowen Therapy uses specific sequences of gentle cross-fibre moves over muscles, tendons, ligaments, and fascia to stimulate or improve the flow of blood and lymph, and thus activate the body's healing mechanisms that enhances tissue repair. As a result, it can lessen pain and tension, restore more optimal body function, and subsequently alleviate emotional and psychological stress associated with the pain. Bowen Therapy is widely recognized and utilized worldwide for acute and chronic health conditions from new-born to the elderly, both mobilized and bed-ridden patients with no documented evidence to show it has caused any harm or adverse effects.
There are two study groups in this study and patients will be randomized and allocated to either one. One group (Control group) will continue receiving conventional treatment; while another group (Bowen group) will receive 8 sessions of Bowen therapy. The investigators hypothesize that Bowen Therapy is superior to the conventional pain treatment for patients with fibromyalgia.
Detailed description
This study is going to look at the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. 80 patients with fibromyalgia attending pain management clinic will be recruited at Alice Ho Miu Ling Nethersole Hospital after informed consent. They will be randomized into either group (control group or Bowen group). Control group will continue receiving conventional treatment such as follow-ups by pain specialists, taking analgesia, physiotherapy. Bowen group will need to attend 8 sessions of therapy. All subjects will be evaluated at 12th week and 24th week after signing the consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated to receive either conventional treatment or Bowen Therapy, following the computer-generated sequence (1= Control, 2= Bowen Therapy). The randomization sequence will be prepared by a research assistant, who will not take part in the study. The randomization sequence will be placed in a brown, and sealed envelopes: Group 1 (n= 40): Control (conventional treatment); and Group 2 (n= 40): Bowen Therapy.
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Other: ConventionalConventional pain treatment. |
| Bowen | Active comparator | Procedure: BowenPatients will be referred to Occupational Therapist for Bowen therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Widespread pain index (WPI) ≧7 and symptom severity (SS) scale score ≧5 or WPI between 3 and 6 with SS scale score ≧9. The WPI includes evaluation of tender points at 19 regions. Tender point count (TPC) is examined by application of approximately 4 kg/cm2 pressure with the tip of the thumb on those regions.
- Symptoms have been present at a similar level for at least 3 months.
- Patient does not have any disorder that would otherwise explain the pain
- Agrees to participate in the study and agree to discontinue other alternatives treatments except in conditions otherwise approved by the investigators.
Key exclusion criteria (8 listed)
- Patient refusal
- pregnancy
- assessed to be contraindicated to participate by pain specialists due to the presence of other co-morbidities or conditions
- underlining disease that affect mobility of upper limb and lower limb
- known severe psychiatric illness
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 |
|---|---|---|
| ConventionalPatients' condition will be continue managed by pain specialists with regular follow-ups and continue patients' active concurrent pain treatment such as taking analgesics, physiotherapy, massage, chiropractor. | Other | Conventional |
| BowenPatients will be referred to Occupational therapist for Bowen Therapy. There will be a week washout period before the start of Bowen Therapy. During a week washout period and study period, patients can continue taking analgesia, but advised to stop the concurrent treatments which can affect the deep tissue such as massage, physiotherapy, and chiropractic to minimize the counteracting effect on the Bowen's action. During a Bowen Therapy session, patients will lie relaxed on the examination couch wearing loosely fitting clothing or only the affected area being exposed. The therapist applies a series of gentle movements across the body. The gentle movements focus on a body of muscle, tendon or nerve and release tension through the nerve within the area. Each session will last for 30 minutes to an hour. After each session, the next appointment will be given to patients. The first four sessions will be scheduled on weekly basis, and the remaining four on biweekly session. | Procedure or surgery | Bowen |
Primary outcome
Change of Pain Score
Time frame: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
The pain score in Numeric Rating Scale (0-10) for both groups of patients, which 0= no pain to 10=worst pain.
6 secondary outcomes
Change of Endurance strength test of lower extremities
Time frame: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
Change of Endurance strength test of upper extremities
Time frame: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
Change of Brief pain inventory-Short Form (BPI)
Time frame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Change of Hospital anxiety and depression scale (HADS)
Time frame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Change of 36-item Short form Survey (SF-36)
Time frame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Jenkins Sleep Evaluation Questionnaire (JSEQ) for sleep
Time frame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
Pik Yu Chen, RN, BSc, MSc principal investigator
Pain Nurse (Registered Nurse)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional and Bowen in people with Fibromyalgia, run by Alice Ho Miu Ling Nethersole Hospital at 1 site in Hong Kong.
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 8 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 16 Feb 2022. 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 Hong Kong. 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 Winnie Samy, RN, BN, MSc (+85235052734, wsamy@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain Score (time frame: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th 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 16 Feb 2022.