Clinical trial NCT05542225: Effectiveness of Strength Training Versus Flexibility Training in Patients With Fibromyalgia
Official title: Effectiveness of Strength Training Versus Flexibility Training in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

1. Patients with generalized fatigue
2. Polymyalga rheumatica
3. Hyperthyrodism
4. Regional pain syndrome
5. Irritable bowel syndrome
6. Myofascial pain syndrome
7. Chronic cancer pain
8. Lactating mothers
9. Metabolic disorders

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: Health status
timeFrame: 4 weeks
measure: sleep disturbance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
References: