Musculoskeletal InjuryNCT05442476
Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction
A study testing Kinesiotaping, Muscle Energy Technique and conventional physiotherapy in people with Musculoskeletal Injury, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Pregnancy is the main occasion of every woman's life in which numerous episodes of physiological and anatomical adjustments takes place within woman's body to become a mother. Anatomical changes often leads to poor biomechanics and may cause mechanical dysfunction of spine especially lower back.. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Kinesiotaping, Muscle Energy Technique and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jun 2022to 10 Oct 2022
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum with diagnosed cases of SIJD dysfunction (after 3 months of delivery) with age range between 20 to 35 years
- Postpartum with unilateral/bilateral both SIJD
- Postpartum with anterior innominate
Who cannot join
- History of any fracture at lower limb in recent 6 months
- Pregnant females
- Spinal stenosis, spondylolisthesis
- Malignancy of spine or lower limb
- Radiculopathy
- Conditions like diastasis recti, prolapse pelvic organ
- History of recent infection
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ziauddin University
Karachi, Sindh
Sabrina, MPhil
About this study
Official title: Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction Among Postpartum Females- A Randomized Controlled Trial
Pregnancy is the main occasion of every woman's life in which numerous episodes of physiological and anatomical adjustments takes place within woman's body to become a mother. Anatomical changes often leads to poor biomechanics and may cause mechanical dysfunction of spine especially lower back.. Sacroiliac joint (SIJ) goes through most of mobility during the period of pregnancy due to hormone release causes ligamentous laxity that can cause SIJD.
Read the detailed description
Fifty two patients will be randomly divided into two groups i.e. Group-A (n=26) and B (n=26) respectively through simple random sampling, sealed envelope method. Informed consent will be taken from the participant prior to intervention. Baseline assessment will be carried out before the first session of all the recruited participants on four outcome measures using, Patrick's FABER test for provocation of pain, NPRS for intensity of pain, RMDQ for physical disability and PALM Pelvic Inclinometer for pelvic asymmetry respectively. Skin reaction test will be conducted before randomization after the baseline assessment for all participants. A small patch of kinesio tape will be applied to the hip region and the participants will be asked to keep it for 24 hours. If any of the participants will develop allergic reaction, it will be removed immediately and participants with positive results will be excluded from the study. After this test, the allergy-free patients will be randomized into 2 groups for treatment. Participants of Group-A will be applied KT with conventional physiotherapy while Group-B participants will perform MET with conventional physiotherapy. Whereas, both the groups will be given 12 sessions of their respective protocol, comprising 20 minutes, 3 times/week for the duration of 4 weeks. After the end of the intervention, subjects will be reassessed after the last session and data will be collected on the same outcome measures for further evaluation
- Conditions
- Musculoskeletal Injury
- Being tested
- Kinesiotaping, Muscle Energy Technique, conventional physiotherapy
- Keywords
- Sacroiliac joint, Exercise, Muscle energy technique
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
For the KT application, participants will be asked to stand with keeping their feet at shoulder level in a comfortable manner. The patient will be in a standing position with lumbar spine flexion. A 5 cm wide long I-shaped piece of tape will be applied with 80% tension transverse to the patient's painful area and the bilateral SIJ region, with no tension applied to the ends of the tape. Another short piece of tape will be applied with 80% tension at an angle from the painful point to the hip, and no tension will be applied to the ends of the tape. An identical application will be performed on the other side of the sacroiliac region
Muscle Energy TechniqueOther
The subject will be asked for the sitting on the treatment table, back towards the therapist. Then the subject will be taken into flexion, rotation and side bending. When the subject will reach the tolerated limit of flexion, the therapist will ask him to perform extension, sidebending and rotation to the opposite side while holding the breath for 7-10 seconds and rest for 2-3 seconds, then the patient will be asked to release the breath. The therapist will wait for the participant's full exhalation and then will take her further in all the directions of restriction, towards the new barrier. MET will be performed for 10 repetitions.
conventional physiotherapyOther
conventional physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| kinesiotaping | Experimental | Not described Receives: Other: Kinesiotaping; Other: conventional physiotherapy |
| Muscle Energy Technique | Other | Not described Receives: Other: Muscle Energy Technique; Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
It will be used for the participants to assess the disability with low back pain, comprised of 24 items regarding functional status that are likely to be affected by LBP. The scoring of RMQD will show '0' as no disability and '24' as maximum disability
Measured: Baseline
Disability
It will be used for the participants to assess the disability with low back pain, comprised of 24 items regarding functional status that are likely to be affected by LBP. The scoring of RMQD will show '0' as no disability and '24' as maximum disability
Measured: After 4 weeks
Pelvic tilting
PALM device is portable, convenient to use that combines the features of a caliper and inclinometer. It is reliable tool used for measuring pelvic tilting angle/inclination by marking a point just inferior to ASIS; another mark inferior to PSIS. Keeping the calipers of the PALM on these two points to determine the distance in centimeter between two points
Measured: Baseline
Pelvic tilting
PALM device is portable, convenient to use that combines the features of a caliper and inclinometer. It is reliable tool used for measuring pelvic tilting angle/inclination by marking a point just inferior to ASIS; another mark inferior to PSIS. Keeping the calipers of the PALM on these two points to determine the distance in centimeter between two points
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start18 Jun 2022
- Primary completion24 Sep 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442476
- Sponsor's protocol ID
- 5490522REH
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction Among Postpartum Females- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05442476
- Acronym / sponsor ID
- 5490522REH
- Conditions
- Musculoskeletal Injury
- Keywords
- Sacroiliac joint, Exercise, Muscle energy technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 24 Sep 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 5 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.
Pregnancy is the main occasion of every woman's life in which numerous episodes of physiological and anatomical adjustments takes place within woman's body to become a mother. Anatomical changes often leads to poor biomechanics and may cause mechanical dysfunction of spine especially lower back.. Sacroiliac joint (SIJ) goes through most of mobility during the period of pregnancy due to hormone release causes ligamentous laxity that can cause SIJD.
Detailed description
Fifty two patients will be randomly divided into two groups i.e. Group-A (n=26) and B (n=26) respectively through simple random sampling, sealed envelope method. Informed consent will be taken from the participant prior to intervention. Baseline assessment will be carried out before the first session of all the recruited participants on four outcome measures using, Patrick's FABER test for provocation of pain, NPRS for intensity of pain, RMDQ for physical disability and PALM Pelvic Inclinometer for pelvic asymmetry respectively. Skin reaction test will be conducted before randomization after the baseline assessment for all participants. A small patch of kinesio tape will be applied to the hip region and the participants will be asked to keep it for 24 hours. If any of the participants will develop allergic reaction, it will be removed immediately and participants with positive results will be excluded from the study. After this test, the allergy-free patients will be randomized into 2 groups for treatment. Participants of Group-A will be applied KT with conventional physiotherapy while Group-B participants will perform MET with conventional physiotherapy. Whereas, both the groups will be given 12 sessions of their respective protocol, comprising 20 minutes, 3 times/week for the duration of 4 weeks. After the end of the intervention, subjects will be reassessed after the last session and data will be collected on the same outcome measures for further evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesiotaping | Experimental | Other: Kinesiotaping, Other: conventional physiotherapy |
| Muscle Energy Technique | Other | Other: Muscle Energy Technique, Other: conventional physiotherapy |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Postpartum with diagnosed cases of SIJD dysfunction (after 3 months of delivery) with age range between 20 to 35 years
- Postpartum with unilateral/bilateral both SIJD
- Postpartum with anterior innominate
Key exclusion criteria (7 listed)
- History of any fracture at lower limb in recent 6 months
- Pregnant females
- Spinal stenosis, spondylolisthesis
- Malignancy of spine or lower limb
- Radiculopathy
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 |
|---|---|---|
| KinesiotapingFor the KT application, participants will be asked to stand with keeping their feet at shoulder level in a comfortable manner. The patient will be in a standing position with lumbar spine flexion. A 5 cm wide long I-shaped piece of tape will be applied with 80% tension transverse to the patient's painful area and the bilateral SIJ region, with no tension applied to the ends of the tape. Another short piece of tape will be applied with 80% tension at an angle from the painful point to the hip, and no tension will be applied to the ends of the tape. An identical application will be performed on the other side of the sacroiliac region | Other | kinesiotaping |
| Muscle Energy TechniqueThe subject will be asked for the sitting on the treatment table, back towards the therapist. Then the subject will be taken into flexion, rotation and side bending. When the subject will reach the tolerated limit of flexion, the therapist will ask him to perform extension, sidebending and rotation to the opposite side while holding the breath for 7-10 seconds and rest for 2-3 seconds, then the patient will be asked to release the breath. The therapist will wait for the participant's full exhalation and then will take her further in all the directions of restriction, towards the new barrier. MET will be performed for 10 repetitions. | Other | Muscle Energy Technique |
| conventional physiotherapyconventional physiotherapy | Other | Muscle Energy Technique, kinesiotaping |
Primary outcome
Disability
Time frame: Baseline
It will be used for the participants to assess the disability with low back pain, comprised of 24 items regarding functional status that are likely to be affected by LBP. The scoring of RMQD will show '0' as no disability and '24' as maximum disability
Disability
Time frame: After 4 weeks
It will be used for the participants to assess the disability with low back pain, comprised of 24 items regarding functional status that are likely to be affected by LBP. The scoring of RMQD will show '0' as no disability and '24' as maximum disability
Pelvic tilting
Time frame: Baseline
PALM device is portable, convenient to use that combines the features of a caliper and inclinometer. It is reliable tool used for measuring pelvic tilting angle/inclination by marking a point just inferior to ASIS; another mark inferior to PSIS. Keeping the calipers of the PALM on these two points to determine the distance in centimeter between two points
Pelvic tilting
Time frame: After 4 weeks
PALM device is portable, convenient to use that combines the features of a caliper and inclinometer. It is reliable tool used for measuring pelvic tilting angle/inclination by marking a point just inferior to ASIS; another mark inferior to PSIS. Keeping the calipers of the PALM on these two points to determine the distance in centimeter between two points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping, Muscle Energy Technique and conventional physiotherapy in people with Musculoskeletal Injury, run by Ziauddin 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Principal Investigator, MPhil (03013972147, sabrina10847@zu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: Baseline). The study lists 4 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 5 Jul 2022.