Neck PainNCT05475392
Effects of Post Isometric Relaxation With and Without Stretching Exercises on Neck Pain and Muscle Spasm
A study testing Traditional Physical Therapy and Post Isometric Relaxation in people with Neck Pain and Muscle Spasm, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Neck Pain, Muscle Spasm
- What is being tested?
- Traditional Physical Therapy and Post Isometric Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Jinnah Hospital , Gynea Ward, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain, Muscle Spasm
- Being tested
- Traditional Physical Therapy, Post Isometric Relaxation
- Keywords
- Breastfeeding women, Muscle spasm, Neck pain, Post Isometric Relaxation, Stretching
- Medical subject headings
- Neck Pain, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical TherapyOther
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
Post Isometric RelaxationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stretching Exercise with PIR on neck pain and muscle spasm in breastfeeding women | Experimental | 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. Receives: Other: Traditional Physical Therapy; Other: Post Isometric Relaxation |
| Stretching Exercise without PIR on neck pain and muscle spasm in breastfeeding women | Active comparator | 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. Receives: Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Weeks
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.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2023
- Primary completion8 Jan 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, M.Phil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475392
- Sponsor's protocol ID
- REC/RCR & AHS/22/0523
- Status last verified
- Jun 2023
- First submitted
- 24 Jul 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35593596Rani 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.
PubMed 31000863Romanowski 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.
PubMed 32922504Lewit K, Simons DG. Myofascial pain: relief by post-isometric relaxation. Arch Phys Med Rehabil. 1984 Aug;65(8):452-6.
PubMed 6466075
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stretching Exercises With and Without Post Isometric Relaxation on Neck Pain and Muscular Spasm in Breastfeeding Women
- ClinicalTrials.gov ID
- NCT05475392
- Acronym / sponsor ID
- REC/RCR & AHS/22/0523
- Conditions
- Neck Pain, Muscle Spasm
- Keywords
- Breastfeeding women, Muscle spasm, Neck pain, Post Isometric Relaxation, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 8 Jan 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching Exercise with PIR on neck pain and muscle spasm in breastfeeding women | Experimental | Other: Traditional Physical Therapy, Other: Post Isometric RelaxationExperimental 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. |
| Stretching Exercise without PIR on neck pain and muscle spasm in breastfeeding women | Active comparator | Other: Traditional Physical TherapyActive 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Physical TherapyA 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 | Other | 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 |
| Post Isometric RelaxationThe 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. | Other | Stretching Exercise with PIR on neck pain and muscle spasm in breastfeeding women |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 35593596Ojukwu 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.
- Background: PubMed 31000863Rani 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.
- Background: PubMed 32922504Romanowski 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.
- Background: PubMed 6466075Lewit K, Simons DG. Myofascial pain: relief by post-isometric relaxation. Arch Phys Med Rehabil. 1984 Aug;65(8):452-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabiha Arshad, M.Phil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy and Post Isometric Relaxation in people with Neck Pain and Muscle Spasm, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analogue Scale) (time frame: 2 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475392, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.