Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05542225 |
| Other study ID # |
FUI/CTR/2022/14 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Foundation University Islamabad |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
