Adhesive CapsulitisNCT06613594
Effects of Kaltenborn Translatoric Glides As Compared to Traction Mobilization in the Management of Frozen Shoulder
A study testing Conventional physical therapy, Kaltenborn traction mobilization and Kaltenborn translatoric glides in people with Adhesive Capsulitis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Frozen shoulder is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Range of motions and capsular pattern affected in frozen shoulder. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Conventional physical therapy, Kaltenborn traction mobilization and Kaltenborn translatoric glides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Aug 2024to 15 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Nonspecific frozen shoulder without specific identifiable etiology (i.e. infection, inflammatory disease)
- 40-65 years of age both males and females.
- Chronic shoulder pain > 3 months.
- Positive capsular pattern.
Who cannot join
- Patients with other shoulder joint pathologies, such as fractures or dislocations, glenohumeral instability or rotator cuff pathologies in the affected shoulder.
- Subjects who have undergone surgery or have experienced an acute trauma to the shoulder.
- Individuals with current or history of neurological disorders (such as stroke, Alzheimer's, or Parkinson's), rheumatologic diseases (such as rheumatoid arthritis or systemic lupus erythematous), or systemic illnesses (such as thyroid disease).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
muhammad Osama, PhD, +92332550436, osama@fui.edu.pk
About this study
Frozen shoulder is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Range of motions and capsular pattern affected in frozen shoulder. Physiotherapists have a wide range of options in managing frozen shoulder including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.some studies on Kaltenborn mobilization , but no obseved comparative effects of Kaltenborn mobilization i.e translatoric glides and traction mobilzation in patients with frozen shoulder.In clinically both techniques of kaltenborn are used but there is no evidence regarding which one is more effective. .If found effective,this study can help to use best clinical treatment in the managemnent of frozen shoulder.
Read the detailed description
Frozen shoulder is a common MSK condition with an insidious onset accompanied by stiffness and trouble sleeping on the affected side.This condition effects General population 2-5% globally, diabetics 10-20%. Women have a significantly higher incidence males 70% of cases are female.frozen shoulder is a painful, gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.
The capsule in frozen shoulder tightens,thickness and adheres to bone it causes severe limiting of both osteikinetics and arthrokinetics shoulder range of motion,resulting in long term functional disability.As the capsule thickens mobility limitations occurs in capsular pattern.Kalternborn traction mobilization helpful in breaking capsular adhesions and decreasein severe pain, Improving shoulder limitation such as external roation ,abduction and internal rotation kaltnborn translatoric glides effective.
These mobilization changes the relative capsular adhesions and reduce stress on Gleno-humeral joint.
In clinically both techniques of kaltnborn joint mobilization are used but there is no evidence which one is more effective in the management of frozen shoulder.
Hence the current study will investigate the effects of Kaltenborn linear tranlatoric glides as compared to traction mobilization mobilization on shoulder range of motion and pain in patients with adhesive capsulitis.
This study includes Subjects with nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease) ,40-65 years of age both males and females and chronic shoulder pain > 3 months,positive capsular pattern.The selection of subjects will be using non-probability purposive sampling technique.Participants will be randomized using sealed envelope method and allocated to one of the 3 groups.
The data collection tools for pain is VAS, for ROM goniometer is used , for FEAR used fear avoidance belief questionnaire and for functional disablity is SPADI.
The time duration for treatment protocol is total of 10 sessions, 5 sessions per week for 2 consecutive weeks for approximately 25-30 mins.
- Conditions
- Adhesive Capsulitis
- Being tested
- Conventional physical therapy, Kaltenborn traction mobilization, Kaltenborn translatoric glides
- Keywords
- chronic pain, kaltenborn traction, kaltenborn linear translatoric glides
- Medical subject headings
- Bursitis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyOther
Patients will receive hot pack, Broom stick ROM exercises, Codman and strengthening exercises. A total of 10 sessions, 5 sessions per week for 2 consecutive weeks.
Kaltenborn traction mobilizationOther
kaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given.
Kaltenborn translatoric glidesOther
Kaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide, such anterior glide for extension and external rotation, caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will performed with 10 reps,rest of 1 minutes between these sets.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy Group | Active comparator | Patients in this group will recieve conventional physical therapy including Hot pack and Tens for 10 to 15 minutes.Broomstick ROM exercises such as Internal \& external rotation,Extension,flexion,abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, 3 sets of 10 reps with 1 minute rest in between will be given, Codman circular motion exercises(1time clockwise ,1 time anticlcock wise) 2-3 times/day with 10reps .Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 weeks. Receives: Other: Conventional physical therapy |
| Conventional physical therapy+kaltenborn traction Group | Experimental | Patients will recieve kaltenborn traction mobiliztion in addition to conventional physical therapy including Hot pack and tens for 10 to 15 minutes , Broomstick ROM exercises such as Flexion, Internal \& external rotation,Extension, Abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day with 10 reps, pain free passive, AAROM.Codman circular motion exercises (1time clockwise ,1 time anticlockwise) 2-3 times/day with 10 reps. kaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given. Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 consecutive weeks. Receives: Other: Conventional physical therapy; Other: Kaltenborn traction mobilization |
| Conventional physical therapy+kaltenborn translatoric glides Group | Experimental | Patient will recieve kaltnborn linear translatoric glides in addittion to Conventional physical therpay including Hot packs and tens for 10-15 minutes. Broomstick ROM exercises such as flexion,Exention,Internal rotation,External roation and Abuction,these are low intensity,short duration,1- 5sec,2-3 times/ day with10 reps,pain free passive, AAROM.Codman exercises circular motion exercises (1time clock wise ,1Time anticlockwise), 2-3 times/day with 10reps. Kaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide,such anterior glide for extension and external rotation,caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will perfromed with 10 reps,rest of 1 minutes between these sets. Strengthening exercises including Isometric in all planes,5sec hold,1 sets of 10 each direction against wall. Every session will be given for 30 minutes and a total of 10 session would be conduted over a period of 2 weeks. Receives: Other: Conventional physical therapy; Other: Kaltenborn translatoric glides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear Avoidance belief
fear of pain to do movement will be assessed by using fear avoidance belief questionnaire .
Measured: 2 weeks
Pain Intensity
Pain will be assessed using Visual Analog scale which is 0-100 item scale.
Measured: 2 weeks
Secondary outcomes (2)
Shoulder Range of motion
Range of motion will be assessed using universal goniometer.
Measured: 2 weeks
Shoulder Disability
Shoulder Disability will be assessed using shoulder pain and disability index.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start20 Aug 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
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 Foundation University IslamabadThe 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
- Model description
- This is a randomized controlled trial having three groups. One group will receive conventional physical therapy, the second will receive conventional physical therapy along with kaltenborn linear translatoric glides and third group recevied conventional therapy along with kaltenborn traction mobilization. All groups will be recruited concurrently.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613594
- Sponsor's protocol ID
- FUI/CTR/2024/28
- Status last verified
- Aug 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kaltenborn Translatoric Glides As Compared to Traction Mobilization in the Management of Frozen Shoulder
- ClinicalTrials.gov ID
- NCT06613594
- Acronym / sponsor ID
- FUI/CTR/2024/28
- Conditions
- Adhesive Capsulitis
- Keywords
- chronic pain, kaltenborn traction, kaltenborn linear translatoric glides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 26 Sep 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.
Frozen shoulder is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Range of motions and capsular pattern affected in frozen shoulder. Physiotherapists have a wide range of options in managing frozen shoulder including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.some studies on Kaltenborn mobilization , but no obseved comparative effects of Kaltenborn mobilization i.e translatoric glides and traction mobilzation in patients with frozen shoulder.In clinically both techniques of kaltenborn are used but there is no evidence regarding which one is more effective. .If found effective,this study can help to use best clinical treatment in the managemnent of frozen shoulder.
Detailed description
Frozen shoulder is a common MSK condition with an insidious onset accompanied by stiffness and trouble sleeping on the affected side.This condition effects General population 2-5% globally, diabetics 10-20%. Women have a significantly higher incidence males 70% of cases are female.frozen shoulder is a painful, gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.
The capsule in frozen shoulder tightens,thickness and adheres to bone it causes severe limiting of both osteikinetics and arthrokinetics shoulder range of motion,resulting in long term functional disability.As the capsule thickens mobility limitations occurs in capsular pattern.Kalternborn traction mobilization helpful in breaking capsular adhesions and decreasein severe pain, Improving shoulder limitation such as external roation ,abduction and internal rotation kaltnborn translatoric glides effective.
These mobilization changes the relative capsular adhesions and reduce stress on Gleno-humeral joint.
In clinically both techniques of kaltnborn joint mobilization are used but there is no evidence which one is more effective in the management of frozen shoulder.
Hence the current study will investigate the effects of Kaltenborn linear tranlatoric glides as compared to traction mobilization mobilization on shoulder range of motion and pain in patients with adhesive capsulitis.
This study includes Subjects with nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease) ,40-65 years of age both males and females and chronic shoulder pain > 3 months,positive capsular pattern.The selection of subjects will be using non-probability purposive sampling technique.Participants will be randomized using sealed envelope method and allocated to one of the 3 groups.
The data collection tools for pain is VAS, for ROM goniometer is used , for FEAR used fear avoidance belief questionnaire and for functional disablity is SPADI.
The time duration for treatment protocol is total of 10 sessions, 5 sessions per week for 2 consecutive weeks for approximately 25-30 mins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized controlled trial having three groups. One group will receive conventional physical therapy, the second will receive conventional physical therapy along with kaltenborn linear translatoric glides and third group recevied conventional therapy along with kaltenborn traction mobilization. All groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy Group | Active comparator | Other: Conventional physical therapyPatients in this group will recieve conventional physical therapy including Hot pack and Tens for 10 to 15 minutes.Broomstick ROM exercises such as Internal \& external rotation,Extension,flexion,abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, 3 sets of 10 reps with 1 minute rest in between will be given, Codman circular motion exercises(1time clockwise ,1 time anticlcock wise) 2-3 times/day with 10reps .Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 weeks. |
| Conventional physical therapy+kaltenborn traction Group | Experimental | Other: Conventional physical therapy, Other: Kaltenborn traction mobilizationPatients will recieve kaltenborn traction mobiliztion in addition to conventional physical therapy including Hot pack and tens for 10 to 15 minutes , Broomstick ROM exercises such as Flexion, Internal \& external rotation,Extension, Abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day with 10 reps, pain free passive, AAROM.Codman circular motion exercises (1time clockwise ,1 time anticlockwise) 2-3 times/day with 10 reps. kaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given. Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 consecutive weeks. |
| Conventional physical therapy+kaltenborn translatoric glides Group | Experimental | Other: Conventional physical therapy, Other: Kaltenborn translatoric glidesPatient will recieve kaltnborn linear translatoric glides in addittion to Conventional physical therpay including Hot packs and tens for 10-15 minutes. Broomstick ROM exercises such as flexion,Exention,Internal rotation,External roation and Abuction,these are low intensity,short duration,1- 5sec,2-3 times/ day with10 reps,pain free passive, AAROM.Codman exercises circular motion exercises (1time clock wise ,1Time anticlockwise), 2-3 times/day with 10reps. Kaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide,such anterior glide for extension and external rotation,caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will perfromed with 10 reps,rest of 1 minutes between these sets. Strengthening exercises including Isometric in all planes,5sec hold,1 sets of 10 each direction against wall. Every session will be given for 30 minutes and a total of 10 session would be conduted over a period of 2 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with Nonspecific frozen shoulder without specific identifiable etiology (i.e. infection, inflammatory disease)
- 40-65 years of age both males and females.
- Chronic shoulder pain > 3 months.
- Positive capsular pattern.
Key exclusion criteria (3 listed)
- Patients with other shoulder joint pathologies, such as fractures or dislocations, glenohumeral instability or rotator cuff pathologies in the affected shoulder.
- Subjects who have undergone surgery or have experienced an acute trauma to the shoulder.
- Individuals with current or history of neurological disorders (such as stroke, Alzheimer's, or Parkinson's), rheumatologic diseases (such as rheumatoid arthritis or systemic lupus erythematous), or systemic illnesses (such as thyroid disease).
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 |
|---|---|---|
| Conventional physical therapyPatients will receive hot pack, Broom stick ROM exercises, Codman and strengthening exercises. A total of 10 sessions, 5 sessions per week for 2 consecutive weeks. | Other | Conventional Physical Therapy Group, Conventional physical therapy+kaltenborn traction Group, Conventional physical therapy+kaltenborn translatoric glides Group |
| Kaltenborn traction mobilizationkaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given. | Other | Conventional physical therapy+kaltenborn traction Group |
| Kaltenborn translatoric glidesKaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide, such anterior glide for extension and external rotation, caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will performed with 10 reps,rest of 1 minutes between these sets. | Other | Conventional physical therapy+kaltenborn translatoric glides Group |
Primary outcome
Fear Avoidance belief
Time frame: 2 weeks
fear of pain to do movement will be assessed by using fear avoidance belief questionnaire .
Pain Intensity
Time frame: 2 weeks
Pain will be assessed using Visual Analog scale which is 0-100 item scale.
2 secondary outcomes
Shoulder Range of motion
Time frame: 2 weeks
Shoulder Disability
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy, Kaltenborn traction mobilization and Kaltenborn translatoric glides in people with Adhesive Capsulitis, run by Foundation University Islamabad 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 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: status not confirmed, as of the sponsor's last update on 26 Sep 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?
Contact Afifa Zuha, MS-MSKPT* (+92334948496, Afifabhattis123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear Avoidance belief (time frame: 2 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 26 Sep 2024.