Combined Effects of Progressive Relaxation Exercises and Aquatic Therapy in Fibromyalgia.
NCT Number: NCT06460636
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: OTHER: progressive muscle relaxation therapy|OTHER: aquatic therapy
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-10
Completion Date: 2024-07-10
Locations: City Hospital, Rahim Yar Khan, Rahimyar Khan, Punjab, 64200, Pakistan

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.

Primary Outcome Measures: 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., 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., 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(, 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(, 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, 8 weeks