Effectiveness of Strength Training Versus Flexibility Training in Patients With Fibromyalgia

NCT05542225 | Unknown

• 1 other identifier: FUI/CTR/2022/14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is a rare musculoskeletal condition worldwide.This condition has a significant impact on the person's quality of life by affecting their various activities of daily living. It is a chronic illness characterized by persistent and widespread non-inflammmtory musculoskeletal pain. Various management strategies including both pharmacological and non-pharmacological are used for the treatment of fibromyalgia. In the recent years strength training and flexibility training are being used for the treatment of fibromyalgia. Strength training is used to improve muscle strength, endurance , power or a combination of both, whereas flexibility training is used to improve ability of a joint to maintain the movement. Different studies have shown postive results of strength training and flexibility training in patients with fibromyalgia. However no such study has investigated the combined effects of both theses techniques. So this study aims to investigate the effect of strength training and flexibility training according to the guidelines of FITT protocol.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be measured on numeric rating pain scale. It consists of 11 points( interval 0-10), where 0 corresponds to no pain and 10 corresponds to worst pain imaginable. A graphical representation of 11 spaces is used for patients own evaluation of his or her pain.

  4 weeks

Secondary Outcomes (2)

• Health status

  4 weeks

• sleep disturbance

  4 weeks

Study Arms (2)

conventional physical therapy with strength training

EXPERIMENTAL

TENS with a frequency of 2-125Hz for about 30mins in prone position. FITT guidelines for strength training: frequency: 2-3 times perweek, time: 3o mins for the whole session, intensity: 8-15 repetitions and type : major muscles( shoulder flexors and extensors, hip and knee flexors, hip abductors and adductors, foot plantar flexors and dorsiflexors using resistance bands)

Procedure: Strength training; Procedure: Standard therapy

conventional physical therapy with flexibility training

ACTIVE COMPARATOR

TENS with a frequency of 2-125 Hz for 30 minutes. FITT guidelines for flexibility; frequency: 5 times per week, intensity: stop before it becomes painful, time: 10-15 minutes,hold for 15 secs and type: major muscle groups( latissmus dorsi, trapezius, gluteus maximus, gluteus medius, gatrocnemius, soleus, hamstringsand paraspinals( errector spinae and multifidus through static stretching technique.

Procedure: Flexibility training; Procedure: Standard therapy

Interventions

Strength training PROCEDURE

Strength training will be performed with the patient in supine lying position as per FITT guidelines in which resistance will be given with the help of resistance bands on major muscle groups including shoulder flexors and extensors, hip and knee flexors and extensors, hip abductors and adductors,foot plantar flexors and dorsiflexors at an intensity of 8-15 repetitions, 2-3 times per week for 30 minutes.

conventional physical therapy with strength training

Flexibility training PROCEDURE

Flexibility training will be performed with the patient in supine lying position as per FITT guidelines. Static stretching will be applied to the major muscle groups( trapezius, latissmus dorsi, gluteus maximus and medius, gastrocnemus, soleus, hamstrings and paraspinals( errector spinae and multifidi. Session will be completed in 10-15 minutes with a hold of 15 secs, 5 times per week. Stop before it becomes painful.

conventional physical therapy with flexibility training

Standard therapy PROCEDURE

TENS at frequency of 2-125Hz for 30 minutes, pharmacological intervention

conventional physical therapy with flexibility training; conventional physical therapy with strength training

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed cases of fibromyalgia according to diagnostic criteria of ACR 2010 referred from Rheumatology department of FFH.
• Both males and females adults with an age of 35-60 years

You may not qualify if:

• Patients with generalized fatigue
• Polymyalga rheumatica
• Hyperthyrodism
• Regional pain syndrome
• Irritable bowel syndrome
• Myofascial pain syndrome
• Chronic cancer pain
• Lactating mothers
• Metabolic disorders

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 4600, Pakistan

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Resistance Training; Standard of Care

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be a another person who will be unaware of the group the particpant belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized controlled trial which will consist of two groups. Once will recieve conventional physcial therapy and the sencond will recieve conventional physcial therapy and slump stretching.Both groups will be recruited concurrently.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

PA (1)