Combined Effects of Progressive Relaxation Exercises and Aquatic Therapy in Fibromyalgia.

June 11, 2024 updated by: Riphah International University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rahimyar Khan, Punjab, Pakistan, 64200
        • Recruiting
        • City Hospital, Rahim Yar Khan
        • Contact:
        • Sub-Investigator:
          • Wajeeha Naveed, DPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive muscle relaxation therapy + Aquatic therapy
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
Other: progressive muscle relaxation therapy
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
Other: aquatic therapy
participants will receive aquatic therapy. Sessions will be conducted twice a week for 8 weeks and duration will be 30 minutes. 16 sessions overall.
Active Comparator: Progressive muscle relaxation therapy
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
Other: progressive muscle relaxation therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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(
8 weeks
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(
8 weeks
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, M.Phill, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 10, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0585

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on progressive muscle relaxation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe