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Effects of Post Isometric Relaxation With and Without Stretching Exercises on Neck Pain and Muscle Spasm

Primary Purpose

Neck Pain, Muscle Spasm

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Traditional Physical Therapy
Post Isometric Relaxation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Breastfeeding women, Muscle spasm, Neck pain, Post Isometric Relaxation, Stretching

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jinnah Hospital , Gynea Ward, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stretching Exercise with PIR on neck pain and muscle spasm in breastfeeding women

Stretching Exercise without PIR on neck pain and muscle spasm in breastfeeding women

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

VAS (Visual Analogue Scale)
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.
MMJ questionnaire (Muscle and Joint Measure)
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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2022
Last Updated
June 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05475392
Brief Title
Effects of Post Isometric Relaxation With and Without Stretching Exercises on Neck Pain and Muscle Spasm
Official Title
Effects of Stretching Exercises With and Without Post Isometric Relaxation on Neck Pain and Muscular Spasm in Breastfeeding Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 8, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Muscle Spasm
Keywords
Breastfeeding women, Muscle spasm, Neck pain, Post Isometric Relaxation, Stretching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stretching Exercise with PIR on neck pain and muscle spasm in breastfeeding women
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching Exercise without PIR on neck pain and muscle spasm in breastfeeding women
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Post Isometric Relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS (Visual Analogue Scale)
Description
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.
Time Frame
2 Weeks
Title
MMJ questionnaire (Muscle and Joint Measure)
Description
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.
Time Frame
2 Weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast Feeding Women
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.Phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital , Gynea Ward, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35593596
Citation
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.
Results Reference
background
PubMed Identifier
31000863
Citation
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.
Results Reference
background
PubMed Identifier
32922504
Citation
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.
Results Reference
background
PubMed Identifier
6466075
Citation
Lewit K, Simons DG. Myofascial pain: relief by post-isometric relaxation. Arch Phys Med Rehabil. 1984 Aug;65(8):452-6.
Results Reference
background

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Effects of Post Isometric Relaxation With and Without Stretching Exercises on Neck Pain and Muscle Spasm

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