Adhesive CapsulitisNCT06181461
Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis
A study testing Gong's Mobilization and Kaltenborn Mobilization in people with Adhesive Capsulitis and Frozen Shoulder, run by University of Lahore at 1 site in Pakistan.
Trial summary
The study will be a Randomized Clinical Trial set to take place at the Department of Physical Therapy, University of Lahore Teaching Hospital, Defence Road, Lahore. It is projected to span 9 months, beginning after the approval of the synopsis. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Adhesive Capsulitis, Frozen Shoulder
- What is being tested?
- Gong's Mobilization and Kaltenborn Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Sep 2023to 30 Mar 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 40-60 years
- Both Male and females
- Patients diagnosed with idiopathic Adhesive Capsulitis
- Patients with 2nd and 3rd stage of Adhesive Capsulitis
- Having at least 5 score of Numeric Pain Rating Scale
Who cannot join
- Patients with neurological disorders(Thoracic Outlet Syndrome)
- Patients with musculoskeletal disorder(e.g. Rotator Cuff Injury)
- Recent fracture/dislocation in and around the shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Patients With Adhesive Capsulitis
The study will be a Randomized Clinical Trial set to take place at the Department of Physical Therapy, University of Lahore Teaching Hospital, Defence Road, Lahore. It is projected to span 9 months, beginning after the approval of the synopsis. The calculated sample size, utilizing Visual Analogue Scale as an outcome measure with a 20% dropout consideration, will be 34 in each group. Ethical approval from the Research Ethical Committee will be sought, and participant referrals will be facilitated by orthopedic physicians. Eligibility screening will be carried out, and willing participants will be randomized into Experimental and Comparative groups using a lottery method. The study will maintain single-blinding, with assessors remaining unaware of group allocation.
Read the detailed description
This research is centered on the comparative effectiveness of Gong's and Kaltenborn's mobilization techniques in the treatment of Adhesive Capsulitis, addressing a significant void in current literature. Prior studies have individually showcased the efficacy of both techniques in enhancing pain relief, expanding range of motion, and improving functional outcomes among patients. However, a direct comparative analysis between Gong's and Kaltenborn's mobilization is conspicuously absent, prompting this study to unveil potential distinctions in their impact on shoulder pain, range of motion, and functional mobility.
The research design involves the random allocation of participants into two groups: Group A, receiving Gong's mobilization, and Group B, undergoing Kaltenborn's mobilization. This allocation will be done through a lottery method, ensuring a fair and unbiased selection process. The study will follow a single-blind design, with the assessor remaining unaware of the treatment group assignment.
Participants in both groups will also receive routine physical therapy, including 15 minutes of electrical muscle stimulation with heat therapy. This approach, supported by existing literature, aims to create a standardized baseline for assessing the additional impact of mobilization techniques. The study's duration is projected to be nine months, with data collection points at baseline, the end of 1.5 weeks, and the conclusion of the 3rd week.
Outcome variables include pain assessment using the Numeric Pain Rating Scale, evaluation of function through the Shoulder Pain \& Disability Index, and measurement of range of motion using goniometry. Data collection will be performed by an assessor at specified intervals, allowing for a comprehensive understanding of the interventions' effects over time.
Ultimately, this research aspires to contribute evidence-based insights into the relative effectiveness of Gong's and Kaltenborn's mobilization techniques, aiding clinicians in making informed decisions for optimal patient outcomes in the context of Adhesive Capsulitis.
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Being tested
- Gong's Mobilization, Kaltenborn Mobilization
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gong's MobilizationOther
Group A received Gong's mobilization with routine physical therapy included a 30-45 min session with 15-min TENS. Patients followed daily care instructions, using the affected shoulder in daily activities, and performed pendulum and active shoulder exercises twice a day.
Kaltenborn MobilizationOther
Group B will receive Kaltenborn mobilization (Grade III posterior translation) with routine therapy. Posterior translation is applied in 30-sec sets, repeated 15 times over 10 mins, with 10-sec rests. Routine physical therapy includes 30-45 min sessions with 15-min TENS. Patients follow daily care instructions, use the affected shoulder in daily activities, and perform pendulum and active shoulder exercises twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Gong's Mobilization | Experimental | Group A received Gong's mobilization with routine physical therapy included a 30-45 min session with 15-min TENS. Patients followed daily care instructions, using the affected shoulder in daily activities, and performed pendulum and active shoulder exercises twice a day. Receives: Other: Gong's Mobilization |
| Kaltenborn Mobilization | Experimental | Group B will receive Kaltenborn mobilization (Grade III posterior translation) with routine therapy. Posterior translation is applied in 30-sec sets, repeated 15 times over 10 mins, with 10-sec rests. Routine physical therapy includes 30-45 min sessions with 15-min TENS. Patients follow daily care instructions, use the affected shoulder in daily activities, and perform pendulum and active shoulder exercises twice a day. Receives: Other: Kaltenborn Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Shoulder Pain & disability Index (SPADI)
The Shoulder Pain \& Disability Index (SPADI) was designed to evaluate shoulder pain and impairment in an outpatient setting. Comprising 13 items, it assesses two domains: a 5-item pain subscale and an 8-item disability subscale. In contrast to the Visual Analog Scale (VAS), the SPADI utilizes a 0-10 scale, with patients circling the number that best represents their pain or disability level, ranging from 0 for minor pain to 10 for severe pain. The total score is calculated similarly to the VAS version. Patients have the option to deem one item as not applicable in each subscale, and that specific item is excluded from the overall score, offering a comprehensive yet adaptable assessment of shoulder pain and disability.
Measured: 3 weeks
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) serves as a segmented numeric alternative to the Visual Analog Scale (VAS), allowing respondents to choose a whole number (0-10 integers) that most accurately represents the intensity of their pain. Typically presented as a horizontal bar or line, the NPRS is a quick and straightforward assessment tool, taking less than a minute to complete. Scores on the NPRS range from 0 to 10 points, with higher scores indicative of more intense pain. This scale is versatile, as it can be administered verbally, making it suitable for telephone assessments, or graphically for self-completion, offering a practical means of gauging pain intensity.
Measured: 3 weeks
Universal Goniometer
The universal goniometer is a crucial tool for assessing shoulder range of motion (ROM). With its protractor-like design, it allows precise measurement of angles in various planes, aiding clinicians in objectively evaluating flexion, extension, abduction, adduction, internal rotation, and external rotation. This device, aligned with joint axes, provides quantitative data for diagnosing conditions, monitoring progress, and guiding treatment plans in orthopedics and rehabilitation.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start28 Sep 2023
- Primary completion20 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Gull, MSPT MSK*, Principal investigator, University of LahoreHafiza Sana Ashraf, MSPT MSK, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181461
- Sponsor's protocol ID
- REC-UOL-528-09-2023
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06181461
- Acronym / sponsor ID
- REC-UOL-528-09-2023
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 26 Dec 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.
The study will be a Randomized Clinical Trial set to take place at the Department of Physical Therapy, University of Lahore Teaching Hospital, Defence Road, Lahore. It is projected to span 9 months, beginning after the approval of the synopsis. The calculated sample size, utilizing Visual Analogue Scale as an outcome measure with a 20% dropout consideration, will be 34 in each group. Ethical approval from the Research Ethical Committee will be sought, and participant referrals will be facilitated by orthopedic physicians. Eligibility screening will be carried out, and willing participants will be randomized into Experimental and Comparative groups using a lottery method. The study will maintain single-blinding, with assessors remaining unaware of group allocation.
Detailed description
This research is centered on the comparative effectiveness of Gong's and Kaltenborn's mobilization techniques in the treatment of Adhesive Capsulitis, addressing a significant void in current literature. Prior studies have individually showcased the efficacy of both techniques in enhancing pain relief, expanding range of motion, and improving functional outcomes among patients. However, a direct comparative analysis between Gong's and Kaltenborn's mobilization is conspicuously absent, prompting this study to unveil potential distinctions in their impact on shoulder pain, range of motion, and functional mobility.
The research design involves the random allocation of participants into two groups: Group A, receiving Gong's mobilization, and Group B, undergoing Kaltenborn's mobilization. This allocation will be done through a lottery method, ensuring a fair and unbiased selection process. The study will follow a single-blind design, with the assessor remaining unaware of the treatment group assignment.
Participants in both groups will also receive routine physical therapy, including 15 minutes of electrical muscle stimulation with heat therapy. This approach, supported by existing literature, aims to create a standardized baseline for assessing the additional impact of mobilization techniques. The study's duration is projected to be nine months, with data collection points at baseline, the end of 1.5 weeks, and the conclusion of the 3rd week.
Outcome variables include pain assessment using the Numeric Pain Rating Scale, evaluation of function through the Shoulder Pain \& Disability Index, and measurement of range of motion using goniometry. Data collection will be performed by an assessor at specified intervals, allowing for a comprehensive understanding of the interventions' effects over time.
Ultimately, this research aspires to contribute evidence-based insights into the relative effectiveness of Gong's and Kaltenborn's mobilization techniques, aiding clinicians in making informed decisions for optimal patient outcomes in the context of Adhesive Capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gong's Mobilization | Experimental | Other: Gong's MobilizationGroup A received Gong's mobilization with routine physical therapy included a 30-45 min session with 15-min TENS. Patients followed daily care instructions, using the affected shoulder in daily activities, and performed pendulum and active shoulder exercises twice a day. |
| Kaltenborn Mobilization | Experimental | Other: Kaltenborn MobilizationGroup B will receive Kaltenborn mobilization (Grade III posterior translation) with routine therapy. Posterior translation is applied in 30-sec sets, repeated 15 times over 10 mins, with 10-sec rests. Routine physical therapy includes 30-45 min sessions with 15-min TENS. Patients follow daily care instructions, use the affected shoulder in daily activities, and perform pendulum and active shoulder exercises twice a day. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 40-60 years
- Both Male and females
- Patients diagnosed with idiopathic Adhesive Capsulitis
- Patients with 2nd and 3rd stage of Adhesive Capsulitis
- Having at least 5 score of Numeric Pain Rating Scale
Key exclusion criteria (3 listed)
- Patients with neurological disorders(Thoracic Outlet Syndrome)
- Patients with musculoskeletal disorder(e.g. Rotator Cuff Injury)
- Recent fracture/dislocation in and around the shoulder
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 |
|---|---|---|
| Gong's MobilizationGroup A received Gong's mobilization with routine physical therapy included a 30-45 min session with 15-min TENS. Patients followed daily care instructions, using the affected shoulder in daily activities, and performed pendulum and active shoulder exercises twice a day. | Other | Gong's Mobilization |
| Kaltenborn MobilizationGroup B will receive Kaltenborn mobilization (Grade III posterior translation) with routine therapy. Posterior translation is applied in 30-sec sets, repeated 15 times over 10 mins, with 10-sec rests. Routine physical therapy includes 30-45 min sessions with 15-min TENS. Patients follow daily care instructions, use the affected shoulder in daily activities, and perform pendulum and active shoulder exercises twice a day. | Other | Kaltenborn Mobilization |
Primary outcome
The Shoulder Pain & disability Index (SPADI)
Time frame: 3 weeks
The Shoulder Pain \& Disability Index (SPADI) was designed to evaluate shoulder pain and impairment in an outpatient setting. Comprising 13 items, it assesses two domains: a 5-item pain subscale and an 8-item disability subscale. In contrast to the Visual Analog Scale (VAS), the SPADI utilizes a 0-10 scale, with patients circling the number that best represents their pain or disability level, ranging from 0 for minor pain to 10 for severe pain. The total score is calculated similarly to the VAS version. Patients have the option to deem one item as not applicable in each subscale, and that specific item is excluded from the overall score, offering a comprehensive yet adaptable assessment of shoulder pain and disability.
Numeric Pain Rating Scale
Time frame: 3 weeks
The Numeric Pain Rating Scale (NPRS) serves as a segmented numeric alternative to the Visual Analog Scale (VAS), allowing respondents to choose a whole number (0-10 integers) that most accurately represents the intensity of their pain. Typically presented as a horizontal bar or line, the NPRS is a quick and straightforward assessment tool, taking less than a minute to complete. Scores on the NPRS range from 0 to 10 points, with higher scores indicative of more intense pain. This scale is versatile, as it can be administered verbally, making it suitable for telephone assessments, or graphically for self-completion, offering a practical means of gauging pain intensity.
Universal Goniometer
Time frame: 3 weeks
The universal goniometer is a crucial tool for assessing shoulder range of motion (ROM). With its protractor-like design, it allows precise measurement of angles in various planes, aiding clinicians in objectively evaluating flexion, extension, abduction, adduction, internal rotation, and external rotation. This device, aligned with joint axes, provides quantitative data for diagnosing conditions, monitoring progress, and guiding treatment plans in orthopedics and rehabilitation.
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 16 Dec 2024.
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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.
Sara Gull, MSPT MSK* principal investigator
University of Lahore
Hafiza Sana Ashraf, MSPT MSK study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gong's Mobilization and Kaltenborn Mobilization in people with Adhesive Capsulitis and Frozen Shoulder, run by University of Lahore 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 5 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 16 Dec 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?
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?
The Shoulder Pain & disability Index (SPADI) (time frame: 3 weeks). The study lists 3 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 16 Dec 2024.