Sacral DisorderNCT05811325
Kinesio Taping With &Without Craniosacral Therapy in Pregnant Females With SIJ Dysfunction.
A study testing kinesiotaping without craniosacral therapy and kinesiotaping with craniosacral therapy in people with Sacral Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
SIJ dysfunction adversely affects quality of life and causes functional impairment and disability. Although, K taping and craniosacral therapy were previously affective in treating SI joint dysfunction, the combined affects of these intervention have not been compared previously to K taping alone. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Sacral Disorder
- What is being tested?
- kinesiotaping without craniosacral therapy and kinesiotaping with craniosacral therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2022to 30 Jan 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 18-35
- pregnant females in 3rd trimester
- pregnant females with SIJ dysfunction
Who cannot join
- high risk pregnancy
- pregnant females with hypermobility syndrome
- previous pelvic history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kinesio Taping With and Without Craniosacral Therapy on Pain, Disability, and Quality of Life in Pregnent Female With Sacroiliac Joint Dysfunction
SIJ dysfunction adversely affects quality of life and causes functional impairment and disability. Although, K taping and craniosacral therapy were previously affective in treating SI joint dysfunction, the combined affects of these intervention have not been compared previously to K taping alone.
Read the detailed description
This study is a randomized controlled trial and have 30 pregnant women suffering from SIJH dysfunction. There is 2 groups and both have received treatment for 6 weeks. The data on pain is collected through VAS and the data on disability is collected through Oswestry Disability Index, and data on quality of life will be collected using SF-36. Measurements will be taken at the beginning of the study and at the end of the 4th week, at the completion of the study. Data will be analyzed using SPSS.
- Conditions
- Sacral Disorder
- Being tested
- kinesiotaping without craniosacral therapy, kinesiotaping with craniosacral therapy
- Keywords
- Sacro-iliac dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotaping without craniosacral therapyOther
The first treatment group will receive kinesio taping for 6 weeks atleast 4 times per week
kinesiotaping with craniosacral therapyOther
The second treatment group will receive kinesio taping with craniosacral therapy for 6 weeks atleast 4 times per week with each session lasting for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| kinesio taping without craniosacral therapy | Experimental | This group received Kinesio taping for improvement in pain,disability and quality of life. Receives: Other: kinesiotaping without craniosacral therapy |
| kinesio taping group with craniosacral therapy | Active comparator | Group received kinesio Taping with craniosacral therapy for improvement in pain,disability and quality of life. Receives: Other: kinesiotaping with craniosacral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ANALOGUE SCALE
This scale is used to assess pain.
Measured: 6 WEEKS
Oswestry Disability Index
it is used to measure disability.
Measured: 4 weeks
Secondary outcomes (1)
SF-36
Data on quality of life is measured by this scale.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start11 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral DisorderStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- tahreem Masood, Principal investigator, ripah international university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811325
- Sponsor's protocol ID
- REC/RCR&AHS/22/0538
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Taping With and Without Craniosacral Therapy on Pain, Disability, and Quality of Life in Pregnent Female With Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05811325
- Acronym / sponsor ID
- REC/RCR&AHS/22/0538
- Conditions
- Sacral Disorder
- Keywords
- Sacro-iliac dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Apr 2023 (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.
SIJ dysfunction adversely affects quality of life and causes functional impairment and disability. Although, K taping and craniosacral therapy were previously affective in treating SI joint dysfunction, the combined affects of these intervention have not been compared previously to K taping alone.
Detailed description
This study is a randomized controlled trial and have 30 pregnant women suffering from SIJH dysfunction. There is 2 groups and both have received treatment for 6 weeks. The data on pain is collected through VAS and the data on disability is collected through Oswestry Disability Index, and data on quality of life will be collected using SF-36. Measurements will be taken at the beginning of the study and at the end of the 4th week, at the completion of the study. Data will be analyzed using SPSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesio taping without craniosacral therapy | Experimental | Other: kinesiotaping without craniosacral therapyThis group received Kinesio taping for improvement in pain,disability and quality of life. |
| kinesio taping group with craniosacral therapy | Active comparator | Other: kinesiotaping with craniosacral therapyGroup received kinesio Taping with craniosacral therapy for improvement in pain,disability and quality of life. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18-35
- pregnant females in 3rd trimester
- pregnant females with SIJ dysfunction
Key exclusion criteria (3 listed)
- high risk pregnancy
- pregnant females with hypermobility syndrome
- previous pelvic history
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 |
|---|---|---|
| kinesiotaping without craniosacral therapyThe first treatment group will receive kinesio taping for 6 weeks atleast 4 times per week | Other | kinesio taping without craniosacral therapy |
| kinesiotaping with craniosacral therapyThe second treatment group will receive kinesio taping with craniosacral therapy for 6 weeks atleast 4 times per week with each session lasting for 60 minutes | Other | kinesio taping group with craniosacral therapy |
Primary outcome
VISUAL ANALOGUE SCALE
Time frame: 6 WEEKS
This scale is used to assess pain.
Oswestry Disability Index
Time frame: 4 weeks
it is used to measure disability.
1 secondary outcome
SF-36
Time frame: 4 weeks
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 13 Apr 2023.
- 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.
tahreem Masood principal investigator
ripah 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 kinesiotaping without craniosacral therapy and kinesiotaping with craniosacral therapy in people with Sacral Disorder, 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 3 inclusion and 3 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 13 Apr 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?
VISUAL ANALOGUE SCALE (time frame: 6 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?
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 13 Apr 2023.