Frozen ShoulderNCT06377644
Comparing the Efficacy of KT vs DN With Conventional Treatment for Improving QOL and Alleviating Pain in Frozen Shoulder
A study testing Kinesio taping and Dry Needling in people with Frozen Shoulder, run by Superior University at 1 site in Pakistan.
Trial summary
"Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Kinesio taping and Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 5 Jul 2024
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with frozen shoulder
- Pain in the shoulder for at least 2 months before
- Available trigger points for at least one muscle around the shoulder joint (supraspinatus, deltoid, infraspinatus, teres minor, and subscapularis).
- Limited range of motion in internal rotation, external rotation, and abduction.
Who cannot join
- Patients with a history of allergy, pregnancy, or lactation period are excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy of Kinesology Taping Versus Dry Needling With Conventional Treatment for Improving Quality of Life and Alleviating Pain in Frozen Shoulder Patients
"Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy.
Read the detailed description
"Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy.
DN ( dry needling) is applied on trigger points in the muscles (at a time two muscles) muscles would be supraspinatus, infraspinatus, teres minor, subscapularis, deltoid, and also used in myofascial pain around the shoulder joint combine with conventional physical therapy. Applying to the other 15 patients group B Needles with lengths of 25 to 40mm and widths of 0.25mm will be used. Each needle will be used once. 1 to 2 minutes for each trigger point. DN will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week.
- Conditions
- Frozen Shoulder
- Being tested
- Kinesio taping, Dry Needling
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingDiagnostic test
Kinesio taping is a physiotherapy method employed to provide support and stability to muscles and joints while allowing freedom of movement (ROM). The elastic nature of kinesio tape closely resembles that of human skin. After application, kinesio tape rebounds, generating a pulling force that acts as the primary stabilizer for the specific area. Physiotherapy treatments often involve a combination of stretching and strengthening exercises, along with electrotherapy modalities. Additionally, Joint mobilization is a form of passive movement in a broad spectrum of exercise used to treat painful and stiff synovial joints.
Dry NeedlingDiagnostic test
Dry needling is a minimally invasive technique involving the use of a single filament or acupuncture needle to penetrate painful soft tissue areas. From a neurophysiological standpoint, Dry Needling might stimulate A-delta nerve fibers (group III), which could activate inhibitory dorsal horn interneurons containing enkephalin, leading to pain suppression and relief through opioid mechanisms. (DN) may affect microcirculation. Numerous studies have shown that inserting needles into muscles can increase blood flow in both the skin and the muscle in the treated area. It can lead to an immediate reduction in local and referred pains, as well as enhance range of motion (ROM) and correct muscle activity patterns.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Other | Not described Receives: Diagnostic Test: Dry Needling |
| Kinesio taping | Experimental | Not described Receives: Diagnostic Test: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
visual Analog scale
Measured: 6 Month
SPADI
shoulder pain and disability index
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Mar 2024
- Primary completion1 May 2024
- Study completion5 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377644
- Sponsor's protocol ID
- DPT/Batch-Fall19/560
- Status last verified
- May 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 May 2024
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Kinesology Taping Versus Dry Needling With Conventional Treatment for Improving Quality of Life and Alleviating Pain in Frozen Shoulder Patients
- ClinicalTrials.gov ID
- NCT06377644
- Acronym / sponsor ID
- DPT/Batch-Fall19/560
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 5 Jul 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
"Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy.
Detailed description
"Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy.
DN ( dry needling) is applied on trigger points in the muscles (at a time two muscles) muscles would be supraspinatus, infraspinatus, teres minor, subscapularis, deltoid, and also used in myofascial pain around the shoulder joint combine with conventional physical therapy. Applying to the other 15 patients group B Needles with lengths of 25 to 40mm and widths of 0.25mm will be used. Each needle will be used once. 1 to 2 minutes for each trigger point. DN will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Other | Diagnostic Test: Dry Needling |
| Kinesio taping | Experimental | Diagnostic Test: Kinesio taping |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with frozen shoulder
- Pain in the shoulder for at least 2 months before
- Available trigger points for at least one muscle around the shoulder joint (supraspinatus, deltoid, infraspinatus, teres minor, and subscapularis).
- Limited range of motion in internal rotation, external rotation, and abduction.
Key exclusion criteria (1 listed)
- Patients with a history of allergy, pregnancy, or lactation period are excluded from the study.
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 |
|---|---|---|
| Kinesio tapingKinesio taping is a physiotherapy method employed to provide support and stability to muscles and joints while allowing freedom of movement (ROM). The elastic nature of kinesio tape closely resembles that of human skin. After application, kinesio tape rebounds, generating a pulling force that acts as the primary stabilizer for the specific area. Physiotherapy treatments often involve a combination of stretching and strengthening exercises, along with electrotherapy modalities. Additionally, Joint mobilization is a form of passive movement in a broad spectrum of exercise used to treat painful and stiff synovial joints. | Diagnostic test | Kinesio taping |
| Dry NeedlingDry needling is a minimally invasive technique involving the use of a single filament or acupuncture needle to penetrate painful soft tissue areas. From a neurophysiological standpoint, Dry Needling might stimulate A-delta nerve fibers (group III), which could activate inhibitory dorsal horn interneurons containing enkephalin, leading to pain suppression and relief through opioid mechanisms. (DN) may affect microcirculation. Numerous studies have shown that inserting needles into muscles can increase blood flow in both the skin and the muscle in the treated area. It can lead to an immediate reduction in local and referred pains, as well as enhance range of motion (ROM) and correct muscle activity patterns. | Diagnostic test | Dry Needling |
Primary outcome
VAS
Time frame: 6 Month
visual Analog scale
SPADI
Time frame: 6 Months
shoulder pain and disability index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and Dry Needling in people with Frozen Shoulder, run by Superior 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 1 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 22 May 2024. 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?
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 (time frame: 6 Month). 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 22 May 2024.