Effectiveness of Strength Training Versus Flexibility Training in Patients With Fibromyalgia

Sponsor

Foundation University Islamabad (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05542225

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Procedure: Strength training Procedure: Flexibility training Procedure: Standard therapy	N/A

Detailed Description

Fibromyalgia is defined as a chronic illness chracterized by widespread and persistent non-inflammatory musculoskeletal pain including both clinical and emotional symptoms.It is experienced by 2-4.7% of the general population. Commonly it occurs in females as compared to males with a ratio of 3:1 according to ACR criteria 1990.Regarding its clinical features fibromyalgia includes morning stiffness, fatigue, insomnia, mood disorders, anxiety, depression, headaches and other cognitive disorders.Different management strategies including physical therapy are used to treat fibromyalgia. In the recent years strength training and flexibility training are used . strength training is used to improve muscle strength, endurance, power or a combination of both whereas flexibility training improves the mobility of the joint to maintain the movement necessary for carrying out the daily tasks and physical activity. Different studies have shown postive effects of strength training and flexibility training in patients with fibromyalgia. However, there is a lack of literature on the combined effects of strength training and flexibility training according to guidelines of FITT protocol.So this study aims to investigate this aspect.

This Randomized controlled trial will be conducted in Rheumatology Opd of Fauji Foundation hospital using non probability purposive sampling. Initially pilot study with sample size of 10 will be calcullated. Then on the basis of mean difference of participants sample size will be calculated using open epi tool..Patients with diagnosed cases of fibromyalgia in the rheumatology opd of FFH will be recruited according to the eligibility criteria. Participants will be briefed regarding the study objectives, study procedures, risks and benefits of treatment, voluntary participation and right to withdraw. After taking informed consent, basic demographical data and baseline measurements, participants will be randomly allocated into one of the two groups using sealed envelope method. Control group will receive conventional physiotherapy along with flexibility training whereas the experimental group will receive Conventional physiotherapy along with strength training.

Group 1(Control group): TENS at a frequency of 2-125 Hz for 30 minutes, FITT protocol of flexibility training: frequency 5 times per week, intensity: stop before it becomes painful, time: 10-15min, hold for 15 secs and type : major muscle groups( trapezius, latissmus dorsi, gluteus maximus and medius, gastrocnemius, soleus and paraspinals(erector spinae and multifidi) through static stretching.

Group 2(Experimental group): TENS at a frequency of 2-125Hz for 30 minutes, FITT protocol for strength training: frequency 2-3 times per week, intensity :8-15 repetitions, time: 30 minutes for the whole session and type: major muscle groups( shoulder flexors and extensors, hip and knee flexors and extensors,hip abductors and adductors,foot plantar and dorsiflexors using resistance bands.

FREQUENCY:All these measures will be taken at baseline, after two weeks and then after the completion of 4 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcome assessor will be a another person who will be unaware of the group the particpant belong to.

Primary Purpose:

Treatment

Official Title:

Effectiveness of Strength Training Versus Flexibility Training in Patients With Fibromyalgia

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: conventional physical therapy with strength training 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 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. Procedure: Standard therapy TENS at frequency of 2-125Hz for 30 minutes, pharmacological intervention
Active Comparator: conventional physical therapy with flexibility training 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 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. Procedure: Standard therapy TENS at frequency of 2-125Hz for 30 minutes, pharmacological intervention

Arm

Intervention/Treatment

Experimental: conventional physical therapy with strength training

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

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.

Procedure: Standard therapy

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

Active Comparator: conventional physical therapy with flexibility training

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

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.

Procedure: Standard therapy

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

Outcome Measures

Primary Outcome Measures

Pain intensity [4 weeks]
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.

Secondary Outcome Measures

Health status [4 weeks]
Fibromyalgia impact questionnaire (FIQ)
sleep disturbance [4 weeks]
measured with Medical outcome study sleep scale(MOS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fauji Foundation Hospital	Rawalpindi	Punjab	Pakistan	4600

Sponsors and Collaborators

Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Foundation University Islamabad

ClinicalTrials.gov Identifier:

NCT05542225

Other Study ID Numbers:

FUI/CTR/2022/14

First Posted:

Sep 15, 2022

Last Update Posted:

Sep 15, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Study Results

No Results Posted as of Sep 15, 2022