FibromyalgiaNCT06460636
Combined Effects of Progressive Relaxation Exercises and Aquatic Therapy in Fibromyalgia.
A study testing progressive muscle relaxation therapy and aquatic therapy in people with Fibromyalgia, run by Riphah International University at 1 site in Pakistan.
Trial summary
Fibromyalgia, a chronic pain disorder, presents a significant challenge in healthcare due to its widespread musculoskeletal pain, tenderness, and a spectrum of associated symptoms. This condition profoundly affects patients' physical functions and quality of life, necessitating effective therapeutic interventions. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- progressive muscle relaxation therapy and aquatic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2023to 10 Jul 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with age of 20-39 years will be included in this study
- Married females
- Only female patients will be included in this study.
- Diagnosis of fibromyalgia according to established criteria of the American College of Rheumatology (I-e widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3 - 6 and SS scale score ≥9. Symptoms present at least 3 months(2).
- Patients having Pain in 11 of 18 tender points will be included.
Who cannot join
- Patients with Severe cardiovascular issues will be excluded.
- Patients with recent injuries or surgeries within the last 6 months will be excluded.
- Patients with untreated psychiatric disorders will be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
City Hospital, Rahim Yar Khan
Rahim Yar Khan, Punjab Province, 64200
Sabiha arshad, m.phill, 03248495979, s.arshad@riphah.edu.pk
Wajeeha Naveed, dpt
About this study
Official title: Combined Effects of Progressive Relaxation Exercises and Aquatic Therapy on Clinical Symptoms, Physical Function and Quality of Life in Patients With Fibromyalgia.
Fibromyalgia, a chronic pain disorder, presents a significant challenge in healthcare due to its widespread musculoskeletal pain, tenderness, and a spectrum of associated symptoms. This condition profoundly affects patients' physical functions and quality of life, necessitating effective therapeutic interventions. In this study progressive relaxation technique and aquatic therapy with progressive relaxation technique will be used. In aquatic therapy the buoyancy and water resistance play an important role in pain management. This research project aims to explore the efficacy of a novel therapeutic approach by combining progressive relaxation exercises with aquatic therapy.
This will be a randomized controlled trial in which non-probability convenience sampling technique will be used. Sample size will be 54 and this study will be conducted in city hospital, Rahim Yar khan. The study duration will be 7 months participants will be divided into 2 groups (27 in each group). The data will be assessed pre values and post values after 8 week of treatment with the help of visual analog scale for pain, fibromyalgia impact questionnaire, berg balance scale, fatigue severity scale and timed up and go. Data will be analyzed with SPSS version 25.
Read the detailed description
Fibromyalgia, a chronic pain disorder, presents a significant challenge in healthcare due to its widespread musculoskeletal pain, tenderness, and a spectrum of associated symptoms. This condition profoundly affects patients' physical functions and quality of life, necessitating effective therapeutic interventions. Current treatments primarily focus on symptom management, as there is no known cure for fibromyalgia. There are different interventions used to treat fibromyalgia for example aerobic exercises, resistance exercises, myofascial massage, lymphatic massage. In this study progressive relaxation technique and aquatic therapy with progressive relaxation technique will be used. In aquatic therapy the buoyancy and water resistance play an important role in pain management. This research project aims to explore the efficacy of a novel therapeutic approach by combining progressive relaxation exercises with aquatic therapy.
This will be a randomized controlled trial in which non-probability convenience sampling technique will be used. Sample size will be 54 and this study will be conducted in city hospital, Rahim Yar khan. The study duration will be 7 months participants will be divided into 2 groups (27 in each group). The data will be assessed pre values and post values after 8 week of treatment with the help of visual analog scale for pain, fibromyalgia impact questionnaire for quality of life, berg balance scale, fatigue severity scale for clinical symptoms of fibromyalgia and timed up and go will be used to assess the physical functioning in patients. Data will be analyzed with SPSS version 25.
Keywords: Aquatic Therapy, Fibromyalgia, Physical Function, Progressive Relaxation Exercises, Quality of Life.
- Conditions
- Fibromyalgia
- Being tested
- progressive muscle relaxation therapy, aquatic therapy
- Keywords
- Aquatic Therapy, fibromyalgia, physical function, progressive relaxation exercises, quality of life
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxation therapyOther
Participants will undergo progressive relaxation exercises, including muscle tension and release with deep breathing, held for 5 seconds each. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall
aquatic therapyOther
participants will receive aquatic therapy. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation therapy + Aquatic therapy | Experimental | Participants in group B will receive progressive muscle relaxation therapy and aquatic therapy. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall Receives: Other: progressive muscle relaxation therapy; Other: aquatic therapy |
| Progressive muscle relaxation therapy | Active comparator | Participants in group A will receive progressive muscle relaxation therapy. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall Receives: Other: progressive muscle relaxation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The VAS is a simple and commonly used tool in pain assessment. It consists of a 10 cm line, with endpoints defining extreme limits such as 'no pain' and 'worst imaginable pain.' Participants mark on the line the point that they feel represents their perception of their current state of pain(19). High reliability ICC=0.99(95%CI 0.989 to 0.992). Scoring: The score is determined by measuring the distance from the 'no pain' end of the line to the point that the patient marks.
Measured: 8 weeks
Fibromyalgia Impact Questionnaire (FIQ)
Purpose: To assess the impact of fibromyalgia on daily living. COMBINED EFFECTS OF PROGRESSIVE RELAXATION TECHNIQUE AND AQUATIC THERAPY PATIENTS WITH FIBROMYALGIA 10 Description: The FIQ is a specific questionnaire designed for fibromyalgia patients. It covers aspects such as physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being(20). Reliability 0.56 of pain score to 0.95 for physical function.
Scoring: It consists of 10 items, each scored on a scale, providing a total score that reflects the overall impact of fibromyalgia on the patient.
Measured: 8 weeks
Berg Scale Test
The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. Balance gives an individual the ability to achieve physical movement and further carry out the activities of daily living. Balance can be classified as either static or dynamic. Fibromyalgia is a common chronic pain condition that exerts a considerable impact on a patient's daily activities and quality of life(
Measured: 8 weeks
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. Correlates with depressive symptoms (Beck Depression Inventory) and quality of life(
Measured: 8 weeks
timed up and go test
Mobility is assessed based on time to complete the test: < 10 seconds = normal. < 20 seconds = good mobility; can walk outside alone; does not require a walking aid. < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start10 Dec 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, M.phill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460636
- Sponsor's protocol ID
- REC/RCR&AHS/23/0585
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma J, Zhang T, Li X, Chen X, Zhao Q. Effects of aquatic physical therapy on clinical symptoms, physical function, and quality of life in patients with fibromyalgia: A systematic review and meta-analysis. Physiother Theory Pract. 2024 Feb;40(2):205-223. doi: 10.1080/09593985.2022.2119906. Epub 2022 Sep 4.
PubMed 36062580Kiyak S, Kocoglu-Tanyer D. Effectiveness of progressive muscle relaxation and laughter therapy on mental health and treatment outcomes in women undergoing in vitro fertilization: A randomized controlled trial. Res Nurs Health. 2021 Dec;44(6):945-956. doi: 10.1002/nur.22187. Epub 2021 Oct 3.
PubMed 34605040Viveiro LAP, Gomes GCV, Bacha JMR, Carvas Junior N, Kallas ME, Reis M, Jacob Filho W, Pompeu JE. Reliability, Validity, and Ability to Identity Fall Status of the Berg Balance Scale, Balance Evaluation Systems Test (BESTest), Mini-BESTest, and Brief-BESTest in Older Adults Who Live in Nursing Homes. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E45-E54. doi: 10.1519/JPT.0000000000000215.
PubMed 30407272Naik H, Shao S, Tran KC, Wong AW, Russell JA, Khor E, Nacul L, McKay RJ, Carlsten C, Ryerson CJ, Levin A. Evaluating fatigue in patients recovering from COVID-19: validation of the fatigue severity scale and single item screening questions. Health Qual Life Outcomes. 2022 Dec 27;20(1):170. doi: 10.1186/s12955-022-02082-x.
PubMed 36575437
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Progressive Relaxation Exercises and Aquatic Therapy on Clinical Symptoms, Physical Function and Quality of Life in Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT06460636
- Acronym / sponsor ID
- REC/RCR&AHS/23/0585
- Conditions
- Fibromyalgia
- Keywords
- Aquatic Therapy, fibromyalgia, physical function, progressive relaxation exercises, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
Fibromyalgia, a chronic pain disorder, presents a significant challenge in healthcare due to its widespread musculoskeletal pain, tenderness, and a spectrum of associated symptoms. This condition profoundly affects patients' physical functions and quality of life, necessitating effective therapeutic interventions. In this study progressive relaxation technique and aquatic therapy with progressive relaxation technique will be used. In aquatic therapy the buoyancy and water resistance play an important role in pain management. This research project aims to explore the efficacy of a novel therapeutic approach by combining progressive relaxation exercises with aquatic therapy.
This will be a randomized controlled trial in which non-probability convenience sampling technique will be used. Sample size will be 54 and this study will be conducted in city hospital, Rahim Yar khan. The study duration will be 7 months participants will be divided into 2 groups (27 in each group). The data will be assessed pre values and post values after 8 week of treatment with the help of visual analog scale for pain, fibromyalgia impact questionnaire, berg balance scale, fatigue severity scale and timed up and go. Data will be analyzed with SPSS version 25.
Detailed description
Fibromyalgia, a chronic pain disorder, presents a significant challenge in healthcare due to its widespread musculoskeletal pain, tenderness, and a spectrum of associated symptoms. This condition profoundly affects patients' physical functions and quality of life, necessitating effective therapeutic interventions. Current treatments primarily focus on symptom management, as there is no known cure for fibromyalgia. There are different interventions used to treat fibromyalgia for example aerobic exercises, resistance exercises, myofascial massage, lymphatic massage. In this study progressive relaxation technique and aquatic therapy with progressive relaxation technique will be used. In aquatic therapy the buoyancy and water resistance play an important role in pain management. This research project aims to explore the efficacy of a novel therapeutic approach by combining progressive relaxation exercises with aquatic therapy.
This will be a randomized controlled trial in which non-probability convenience sampling technique will be used. Sample size will be 54 and this study will be conducted in city hospital, Rahim Yar khan. The study duration will be 7 months participants will be divided into 2 groups (27 in each group). The data will be assessed pre values and post values after 8 week of treatment with the help of visual analog scale for pain, fibromyalgia impact questionnaire for quality of life, berg balance scale, fatigue severity scale for clinical symptoms of fibromyalgia and timed up and go will be used to assess the physical functioning in patients. Data will be analyzed with SPSS version 25.
Keywords: Aquatic Therapy, Fibromyalgia, Physical Function, Progressive Relaxation Exercises, Quality of Life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation therapy + Aquatic therapy | Experimental | Other: progressive muscle relaxation therapy, Other: aquatic therapyParticipants in group B will receive progressive muscle relaxation therapy and aquatic therapy. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall |
| Progressive muscle relaxation therapy | Active comparator | Other: progressive muscle relaxation therapyParticipants in group A will receive progressive muscle relaxation therapy. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with age of 20-39 years will be included in this study
- Married females
- Only female patients will be included in this study.
- Diagnosis of fibromyalgia according to established criteria of the American College of Rheumatology (I-e widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3 - 6 and SS scale score ≥9. Symptoms present at least 3 months(2).
- Patients having Pain in 11 of 18 tender points will be included.
Key exclusion criteria (3 listed)
- Patients with Severe cardiovascular issues will be excluded.
- Patients with recent injuries or surgeries within the last 6 months will be excluded.
- Patients with untreated psychiatric disorders will be excluded.
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 |
|---|---|---|
| progressive muscle relaxation therapyParticipants will undergo progressive relaxation exercises, including muscle tension and release with deep breathing, held for 5 seconds each. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall | Other | Progressive muscle relaxation therapy, Progressive muscle relaxation therapy + Aquatic therapy |
| aquatic therapyparticipants will receive aquatic therapy. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall. | Other | Progressive muscle relaxation therapy + Aquatic therapy |
Primary outcome
Visual Analog Scale
Time frame: 8 weeks
The VAS is a simple and commonly used tool in pain assessment. It consists of a 10 cm line, with endpoints defining extreme limits such as 'no pain' and 'worst imaginable pain.' Participants mark on the line the point that they feel represents their perception of their current state of pain(19). High reliability ICC=0.99(95%CI 0.989 to 0.992). Scoring: The score is determined by measuring the distance from the 'no pain' end of the line to the point that the patient marks.
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 8 weeks
Purpose: To assess the impact of fibromyalgia on daily living. COMBINED EFFECTS OF PROGRESSIVE RELAXATION TECHNIQUE AND AQUATIC THERAPY PATIENTS WITH FIBROMYALGIA 10 Description: The FIQ is a specific questionnaire designed for fibromyalgia patients. It covers aspects such as physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being(20). Reliability 0.56 of pain score to 0.95 for physical function. Scoring: It consists of 10 items, each scored on a scale, providing a total score that reflects the overall impact of fibromyalgia on the patient.
Berg Scale Test
Time frame: 8 weeks
The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. Balance gives an individual the ability to achieve physical movement and further carry out the activities of daily living. Balance can be classified as either static or dynamic. Fibromyalgia is a common chronic pain condition that exerts a considerable impact on a patient's daily activities and quality of life(
Fatigue Severity Scale
Time frame: 8 weeks
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. Correlates with depressive symptoms (Beck Depression Inventory) and quality of life(
timed up and go test
Time frame: 8 weeks
Mobility is assessed based on time to complete the test: < 10 seconds = normal. < 20 seconds = good mobility; can walk outside alone; does not require a walking aid. < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 36062580Ma J, Zhang T, Li X, Chen X, Zhao Q. Effects of aquatic physical therapy on clinical symptoms, physical function, and quality of life in patients with fibromyalgia: A systematic review and meta-analysis. Physiother Theory Pract. 2024 Feb;40(2):205-223. doi: 10.1080/09593985.2022.2119906. Epub 2022 Sep 4.
- Background: PubMed 34605040Kiyak S, Kocoglu-Tanyer D. Effectiveness of progressive muscle relaxation and laughter therapy on mental health and treatment outcomes in women undergoing in vitro fertilization: A randomized controlled trial. Res Nurs Health. 2021 Dec;44(6):945-956. doi: 10.1002/nur.22187. Epub 2021 Oct 3.
- Background: PubMed 30407272Viveiro LAP, Gomes GCV, Bacha JMR, Carvas Junior N, Kallas ME, Reis M, Jacob Filho W, Pompeu JE. Reliability, Validity, and Ability to Identity Fall Status of the Berg Balance Scale, Balance Evaluation Systems Test (BESTest), Mini-BESTest, and Brief-BESTest in Older Adults Who Live in Nursing Homes. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E45-E54. doi: 10.1519/JPT.0000000000000215.
- Background: PubMed 36575437Naik H, Shao S, Tran KC, Wong AW, Russell JA, Khor E, Nacul L, McKay RJ, Carlsten C, Ryerson CJ, Levin A. Evaluating fatigue in patients recovering from COVID-19: validation of the fatigue severity scale and single item screening questions. Health Qual Life Outcomes. 2022 Dec 27;20(1):170. doi: 10.1186/s12955-022-02082-x.
- 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.
Sabiha Arshad, M.phill principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive muscle relaxation therapy and aquatic therapy in people with Fibromyalgia, 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 5 inclusion and 3 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 14 Jun 2024. 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 Iqbal Tariq, PhD (03458236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460636, which also lists 4 linked publications.
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 14 Jun 2024.