- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475392
Effects of Post Isometric Relaxation With and Without Stretching Exercises on Neck Pain and Muscle Spasm
June 14, 2023 updated by: Riphah International University
Effects of Stretching Exercises With and Without Post Isometric Relaxation on Neck Pain and Muscular Spasm in Breastfeeding Women
Neck pain is common in the adult general population, disabling and costly Lifetime, which constituted a great problem facing the mother during breast feeding period.
The studies showed that poor knowledge and wrong position for breastfeeding influence their own health as well as baby's health.
Stretching exercises are one of the manual physical therapy methods that can be used in the treatment of mechanical neck pain) Muscle energy techniques (MET) were originally developed to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage.
This study aims at applying stretching along with MET technique (post isometric relaxation) to see the combined effect of these two techniques and comparing that group with another one that is only applied stretching and baseline treatment.
A randomized clinical trial will be undertaken.
Non probability convenient sampling will be used.
Forty-six patients with neck pain and muscular spasm will be randomly allocated.
Twenty-three participants will be allocated with lottery method in each group.
The former group will receive Stretching with MET (post isometric relaxation), and the latter group will receive static stretching only.
Both groups will also receive baseline therapy.
Treatment will be given once a day daily for 14 days.
A visual analogue scale (VAS) will be used to measure the intensity of pain and MMJ questionnaire for muscular spasm.
Data will be collected before and at the end of treatment at the 14th day.
To analyze data SPSS version 29 will be used.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Neck pain is common in the adult general population, disabling and costly Lifetime, which constituted a great problem facing the mother during breast feeding period.
The studies showed that poor knowledge and wrong position for breastfeeding influence their own health as well as baby's health.
Stretching exercises are one of the manual physical therapy methods that can be used in the treatment of mechanical neck pain) Muscle energy techniques (MET) were originally developed to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage.
This study aims at applying stretching along with MET technique (post isometric relaxation) to see the combined effect of these two techniques and comparing that group with another one that is only applied stretching and baseline treatment.
A randomized clinical trial will be undertaken.
Non probability convenient sampling will be used.
Forty-six patients with neck pain and muscular spasm will be randomly allocated.
Twenty-three participants will be allocated with lottery method in each group.
The former group will receive Stretching with MET (post isometric relaxation), and the latter group will receive static stretching only.
Both groups will also receive baseline therapy.
Treatment will be given once a day daily for 14 days.
A visual analogue scale (VAS) will be used to measure the intensity of pain and MMJ questionnaire for muscular spasm.
Data will be collected before and at the end of treatment at the 14th day.
To analyze data SPSS version 29 will be used.
Study Type
Interventional
Enrollment (Actual)
46
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 Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Jinnah Hospital , Gynea Ward, Lahore
-
-
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
21 years to 31 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women of age from 25 to 35years,
- All patients must be in breastfeeding period at least 6 weeks after delivery,
- BMI of women must be less than 30 kg/m²,
- Parity of women must not more than 3 times
Exclusion Criteria:
- Patient should not be in Pregnancy phase.
- There should not be Positive neurological examination
- Cervical spine surgery or stenosis patients should not be included
- Metastases patients should not be included.
- Participants should not have aassociated pathology of the upper cervical region or upper limb that may cause overlapping with the clinical finding as referred pain from costotransverse joint, rotator cuff tendonitis, and cervical rib syndrome
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: Stretching Exercise with PIR on neck pain and muscle spasm in breastfeeding women
Experimental Group (Group A) will receive stretching with Post Isometric Relaxation and conventional treatment.
Treatment will be given for five days per week for total two weeks.
Pain will be assessed through VAS scale and MJM scale will be used to assess spasm.
Assessment was done 2 times pretreatment and post treatment.
|
A 2-week physical therapy program will be arranged.
Each patient will be given 60 min session , 10 min for neck ROMS (10 reps for each ROM) , 10 min neck Isometrics (5 reps on each side) , 30 sec static gentle stretch of levator scapulae (3reps) , 30 sec static gentle stretch of trapezius (3reps), 5 min Soft tissue manipulation , 5 min Shoulder shrugging (10reps) , 10 min for PIR
The exercise will be combined with the baseline treatment 3 sets PIR will be applied per session.The hypertonic muscle is taken to a length just short of pain, or to the point where resistance to movement is first noted.
A submaximal (10-20%) contraction of the hypertonic muscle is performed away from the barrier for between 5 and 10 seconds and the therapist applies resistance in the opposite direction.
The patient should inhale during this effort.
After the isometric contraction, the patient is asked to relax and exhale while doing so.
Following this, a gentle stretch is applied to take up the slack till the new barrier.
Starting from this new barrier, the procedure is repeated two or three times.
|
|
Active Comparator: Stretching Exercise without PIR on neck pain and muscle spasm in breastfeeding women
Active Compatitor (Group B) will receive only stretching and conventional treatment.
Treatment will be given for five days per week for total two weeks.
Pain will be assessed through VAS scale and MJM scale will be used to assess spasm.
Assessment was done 2 times pretreatment and post treatment.
|
A 2-week physical therapy program will be arranged.
Each patient will be given 60 min session , 10 min for neck ROMS (10 reps for each ROM) , 10 min neck Isometrics (5 reps on each side) , 30 sec static gentle stretch of levator scapulae (3reps) , 30 sec static gentle stretch of trapezius (3reps), 5 min Soft tissue manipulation , 5 min Shoulder shrugging (10reps) , 10 min for PIR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS (Visual Analogue Scale)
Time Frame: 2 Weeks
|
For Neck pain.
VAS will be described to patients using a 100 mm horizontal line with 0 representing "no pain" and 10 representing "worst pain imaginable".
Patient marked a point on the line that matched the current amount of the pain he or she felt.
|
2 Weeks
|
|
MMJ questionnaire (Muscle and Joint Measure)
Time Frame: 2 Weeks
|
For muscular spasm.The MJM has potential research and clinical value for addressing the musculoskeletal symptoms.
Readings with 0 to 10 on it.
0 represents to no muscle cramps or spasm at all and 10 represents to cramps and spasms as bad as they can possibly be.
|
2 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sabiha Arshad, M.phil, 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
- Ojukwu CP, Okpoko CG, Ikele IT, Ilo IJ, Ede SS, Anekwu NE, Okemuo AJ, Anekwu EM, Ugwu SU, Ikele CN. Neck Muscles' Responses to Cradle, Cross-cradle and Football Breastfeeding Hold Positions in Nursing Mothers: A Preliminary Study. Niger J Clin Pract. 2022 May;25(5):563-568. doi: 10.4103/njcp.njcp_630_20.
- Rani S, Habiba UE, Qazi WA, Tassadaq N. Association of breast feeding positioning with musculoskeletal pain in post partum mothers of Rawalpindi and Islamabad. J Pak Med Assoc. 2019 Apr;69(4):564-566.
- Romanowski MW, Spiritovic M, Romanowski W, Straburzynska-Lupa A. Manual Therapy (Postisometric Relaxation and Joint Mobilization) in Knee Pain and Function Experienced by Patients with Rheumatoid Arthritis: A Randomized Clinical Pilot Study. Evid Based Complement Alternat Med. 2020 Aug 19;2020:1452579. doi: 10.1155/2020/1452579. eCollection 2020.
- Lewit K, Simons DG. Myofascial pain: relief by post-isometric relaxation. Arch Phys Med Rehabil. 1984 Aug;65(8):452-6.
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)
January 1, 2023
Primary Completion (Actual)
January 8, 2023
Study Completion (Actual)
March 15, 2023
Study Registration Dates
First Submitted
July 24, 2022
First Submitted That Met QC Criteria
July 24, 2022
First Posted (Actual)
July 26, 2022
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0523
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.
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