Musculoskeletal PainNCT04880135
Supervised Versus Home Based Exercises Neck and Low Back Pain Among Students Due to Quarantine During COVID-19
A study testing Supervised stretching and strengthening exercise and Home-based stretching and strengthening exercise in people with Musculoskeletal Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study investigates whether or not the stretching and strengthening exercises are effective both at home and under supervision for people suffering from neck pain from using equipment for online courses due to quarantine during COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Supervised stretching and strengthening exercise and Home-based stretching and strengthening exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 1 Sep 2021
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants using gadget like computer, mobile or laptop for online education during quarantine
- Participants having musculoskeletal pain during COVID-19 quarantine
- Prolonged sitting and low physical activity during quarantine
- Prolonged exposure of screen more than 6 hours per day due online classes during the quarantine
Who cannot join
- Participants having musculoskeletal pain before the quarantine
- Participants doing any type of physical activity during quarantine
- Participants taking online classes or any online educational program before quarantine
- Participants with known congenital, inflammatory and infectious conditions of spine
- Participants following any ergonomic recommendations or any postural awareness during and after quarantine
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Faisalabad, Punjab, Pakistan, 38000
About this study
Official title: Effects of Supervised Versus Home Based Stretching and Strengthening Exercise Program on Neck Pain and Back Pain Among University Students Due to Quarantine During COVID-19: A Randomised Controlled Trial
This study investigates whether or not the stretching and strengthening exercises are effective both at home and under supervision for people suffering from neck pain from using equipment for online courses due to quarantine during COVID-19.
Read the detailed description
The aim of this study is to investigate which regime is best to follow a recommendation, be it under the supervision of the therapist or at home with stretching and strengthening exercises. There was no study that could explain the effect of stretching and strengthening exercises as a comparison between a supervised and a home treatment plan for neck pain in students during quarantine due to Covid-19.This study examines whether or not the recommendations given are effective both at home and under supervision.
- Conditions
- Musculoskeletal Pain
- Being tested
- Supervised stretching and strengthening exercise, Home-based stretching and strengthening exercise
- Keywords
- Musculoskeletal Pain, COVID-19, strengthening exercises, stretching exercises
- Medical subject headings
- Musculoskeletal Pain, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised stretching and strengthening exerciseOther
Also called Rehabilitation following Supervised stretching and strengthening exercise
The structure of the supervised exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes.
Home-based stretching and strengthening exerciseOther
Also called Rehabilitation following Home-based stretching and strengthening exercise
The structure of the home based exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Supervised stretching and strengthening exercise | Experimental | Stretching and strengthening exercises will be performed under the supervision of Physical therapist for a period of one month Receives: Other: Supervised stretching and strengthening exercise |
| Home-based stretching and strengthening exercises | Experimental | Stretching and strengthening exercises will be performed at home by individuals having musculoskeletal pain due to quarantine for a period of one month. Receives: Other: Home-based stretching and strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual analogue scale is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image. 0 indicates no pain while 10 is worst pain.
Measured: 2 month
International Physical Activity Questionnaire
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available.
Measured: 2 months
Neck Disability Index
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life
Measured: 2 months
Oswestry Low Back Pain Disability Questionnaire
Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Questionnaire examines perceived level of disability in 10 everyday activities of daily living.
The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at 5
Measured: 2 months
Nordic Musculoskeletal Questionnaire
Nordic Musculoskeletal Questionnaire was used to provide the level of musculoskeletal pain from the previous 7 days
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Mar 2021
- Primary completion30 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880135
- Sponsor's protocol ID
- REC-FSD-00232
- Status last verified
- Sep 2021
- First submitted
- 6 May 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Versus Home Based Stretching and Strengthening Exercise Program on Neck Pain and Back Pain Among University Students Due to Quarantine During COVID-19: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04880135
- Acronym / sponsor ID
- REC-FSD-00232
- Conditions
- Musculoskeletal Pain
- Keywords
- Musculoskeletal Pain, COVID-19, strengthening exercises, stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 10 May 2021 (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.
This study investigates whether or not the stretching and strengthening exercises are effective both at home and under supervision for people suffering from neck pain from using equipment for online courses due to quarantine during COVID-19.
Detailed description
The aim of this study is to investigate which regime is best to follow a recommendation, be it under the supervision of the therapist or at home with stretching and strengthening exercises. There was no study that could explain the effect of stretching and strengthening exercises as a comparison between a supervised and a home treatment plan for neck pain in students during quarantine due to Covid-19.This study examines whether or not the recommendations given are effective both at home and under supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised stretching and strengthening exercise | Experimental | Other: Supervised stretching and strengthening exerciseStretching and strengthening exercises will be performed under the supervision of Physical therapist for a period of one month |
| Home-based stretching and strengthening exercises | Experimental | Other: Home-based stretching and strengthening exerciseStretching and strengthening exercises will be performed at home by individuals having musculoskeletal pain due to quarantine for a period of one month. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants using gadget like computer, mobile or laptop for online education during quarantine
- Participants having musculoskeletal pain during COVID-19 quarantine
- Prolonged sitting and low physical activity during quarantine
- Prolonged exposure of screen more than 6 hours per day due online classes during the quarantine
Key exclusion criteria (5 listed)
- Participants having musculoskeletal pain before the quarantine
- Participants doing any type of physical activity during quarantine
- Participants taking online classes or any online educational program before quarantine
- Participants with known congenital, inflammatory and infectious conditions of spine
- Participants following any ergonomic recommendations or any postural awareness during and after quarantine
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 |
|---|---|---|
| Supervised stretching and strengthening exerciseAlso: Rehabilitation following Supervised stretching and strengthening exerciseThe structure of the supervised exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes. | Other | Supervised stretching and strengthening exercise |
| Home-based stretching and strengthening exerciseAlso: Rehabilitation following Home-based stretching and strengthening exerciseThe structure of the home based exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes. | Other | Home-based stretching and strengthening exercises |
Primary outcome
Visual Analogue Scale
Time frame: 2 month
The visual analogue scale is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image. 0 indicates no pain while 10 is worst pain.
International Physical Activity Questionnaire
Time frame: 2 months
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available.
Neck Disability Index
Time frame: 2 months
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life
Oswestry Low Back Pain Disability Questionnaire
Time frame: 2 months
Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Questionnaire examines perceived level of disability in 10 everyday activities of daily living. The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at 5
Nordic Musculoskeletal Questionnaire
Time frame: 2 months
Nordic Musculoskeletal Questionnaire was used to provide the level of musculoskeletal pain from the previous 7 days
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 20 Sep 2021.
- 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.
Muhammad Kashif study chair
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 Supervised stretching and strengthening exercise and Home-based stretching and strengthening exercise in people with Musculoskeletal Pain, 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 20 Sep 2021. 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?
Visual Analogue Scale (time frame: 2 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2021.