Clinical trial NCT06460636: Combined Effects of Progressive Relaxation Exercises and Aquatic Therapy in Fibromyalgia.
Official title: Combined Effects of Progressive Relaxation Exercises and Aquatic Therapy on Clinical Symptoms, Physical Function and Quality of Life in Patients With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Aquatic Therapy
fibromyalgia
physical function
progressive relaxation exercises
quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with age of 20-39 years will be included in this study
2. Married females
3. Only female patients will be included in this study.
4. 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).
5. Patients having Pain in 11 of 18 tender points will be included.

Exclusion Criteria:

1. Patients with Severe cardiovascular issues will be excluded.
2. Patients with recent injuries or surgeries within the last 6 months will be excluded.
3. Patients with untreated psychiatric disorders will be excluded.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 8 weeks
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 8 weeks
measure: Berg Scale Test
timeFrame: 8 weeks
measure: Fatigue Severity Scale
timeFrame: 8 weeks
measure: timed up and go test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rahimyar Khan
country: Pakistan
facility: City Hospital, Rahim Yar Khan
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, M.phill
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kiyak 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.
citation: Viveiro 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.
citation: Naik 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.