Frozen ShoulderNCT05931666
Gong v/s Kaltenborn Mobilization in Frozen Shoulder
A study testing Gong Mobilization and Kaltenborn Mobilization in people with Frozen Shoulder, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The aim of this research is to determine the effects of Gong mobilization and Kaltenborn mobilization in patients of frozen shoulder. This is a Randomized clinical trial. The sample size is 40. The subjects are divided in two groups, with 20 subjects in Group A and 20 subjects in Group B. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Gong Mobilization and Kaltenborn Mobilization
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jun 2022to 22 Jun 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral stage-II frozen shoulder.
- Both males and females.
- Subjects within 40- 65 years age.
- Capsular pattern restrictions in ROM (external rotation is more limited than abduction, which is more limited than internal rotation).
Who cannot join
- Subjects with previous surgery of the shoulder joint.
- Subjects with rotator cuff rupture.
- History of recent fracture or severe trauma to the shoulder.
- Restricted shoulder ROM due to burns or postoperative scars.
- Diagnosed instability or previous history of dislocation
- Systemic inflammatory conditions (e.g. rheumatoid arthritis)
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Satellite Specialist Clinic
Rawalpindi, Punjab Province, 46030
Professional Specialist Rehab Center
Rawalpindi, Punjab Province, 48201
About this study
Official title: Comparison of Gong and Kaltenborn Mobilization in Frozen Shoulder
The aim of this research is to determine the effects of Gong mobilization and Kaltenborn mobilization in patients of frozen shoulder. This is a Randomized clinical trial. The sample size is 40. The subjects are divided in two groups, with 20 subjects in Group A and 20 subjects in Group B. Study duration is of 6 months. Sampling technique applied is Nonprobability Purposive Sampling. Both males and females of aged 40-65 years with Stage-II frozen shoulder are included. Tools used in the study are Visual Analogue Scale (VAS), Goniometer, and SPADI (Shoulder pain and disability index) questionnaire.
Read the detailed description
Adhesive capsulitis or periarthritis, more commonly termed as frozen shoulder is a pathological process where adhesions are formed across glenohumeral joint causing debilitating pain and movement restrictions. The pathology is categorized as primary, being idiopathic and occur spontaneously without any inciting event, or secondary which occur as a result of some identifiable disorder such as diabetes mellitus (where a cascade of inflammatory reactions, collagen build-up and other extracellular components lead to tendon fibrosis and dysfunction, presenting as diabetic frozen shoulder) or some other inciting event. The incidence of frozen shoulder is evident to be 3-5% in general population while it's up to 20% in diabetic patients. Further it is more evident in females aged 40-60 years. Moreover frozen shoulder is classified into four stages which include Stage-I characterized by painful shoulder at rest and disturbed sleep, lasting up to 3 months; Stage-II termed the "freezing stage" is identified by chronic pain along with restrictions in range of motion (ROM) and last up to 9 months; Stage-III called the "frozen stage" where a considerable reduction in ROM and a rigid end feel is observed and occurs during 9 to 15 months of onset; Stage-IV is "thawing phase" where ROM improves progressively, as frozen shoulder is a self-limiting condition and lasts from 15 to 24 months.
The standard exercise protocol followed for management of frozen shoulder include active and active assisted exercises, Codman exercises, wall and ladder exercises, wand exercises, capsular stretching, and shoulder joint mobilization. The electrotherapeutic modalities employed include ultrasound to resolve inflammation, interferential therapy and transcutaneous electrical nerve stimulation (TENS) for pain control and thermal therapy to relieve pain and improve muscles extensibility.
Manual therapy techniques of mobilization have been proved to be very effective in treating frozen shoulder. The Gong's mobilization technique which combines the concepts of distraction and Maitland, is explained as end range mobilization where an antero-posterior glide is applied in dynamic position of the shoulder joint followed by distraction and performance of the restricted movement. The technique serves to reduce pain and improve range of motion and is significant in producing immediate effects. Kaltenborn mobilization technique depends on concave rule and gives grades of traction which include loosening, tightening and stretching of the soft connective tissues.
- Conditions
- Frozen Shoulder
- Being tested
- Gong Mobilization, Kaltenborn Mobilization
- Keywords
- Gong mobilization, Kaltenborn mobilization, Frozen shoulder
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gong MobilizationOther
Patients are treated with Gong mobilization protocol along with conventional therapy including ultrasound therapy, hot pack and conventional exercises consisting of codman exercises, ROM exercises and shoulder stabilization exercises.
Total of 3 sessions per week for 3 consecutive weeks.
Kaltenborn MobilizationOther
Patients are treated with Kaltenborn mobilization protocol along with conventional therapy including ultrasound therapy, hot pack and conventional exercises consisting of codman exercises, ROM exercises and shoulder stabilization exercises.
Total of 3 sessions per week for 3 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gong Mobilization | Experimental | The subject placed in a side-lying position with the affected shoulder joint facing upward. and abducted at about 90 degrees to maintain the humerus vertical position with elbow in a 90-degree position. The therapist use one hand to keep the subject's elbow joint at 90 degrees, his elbow below the subject's elbow joint, and the other hand to press the humerus head from anterior to posterior. Therapist elevate own body, pulling on the articular capsule of the shoulder joint. This gentle pulling sustained for 10- 15 seconds before relaxing for 5 seconds; the whole manoeuver last roughly 2-3 minutes. Receives: Other: Gong Mobilization |
| Kaltenborn Mobilization | Experimental | Patient lies supine on the table with the arm abducted approximately to 55⁰. The therapist stands facing the lateral side of upper arm. The scapula is fixed using a towel. The therapist's right hand holds around the patients elbow \& forearm from the ventral side. Left hand holds around the humeral head with the thumb ventrally just distal to the acromion \& the direction of movement is towards caudal assisted by therapist's body. Also anterior and posterior glides are applied with patient positioned similarly in supine lying to improve mobility at the shoulder joint. Receives: Other: Kaltenborn Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain and disability index
SPADI was developed to measure the pain and disability associated with shoulder pathology. The SPADI is a self-administered index consisting of 13 items divided into two subscales i.e. pain and disability. A remarkably good internal consistency and high test-retest reliability value was found (ICC for pain=0.989 [95% CI=0.975-0.995]; ICC for disability=0.990 [95% CI=0.988-0.998]
Measured: 3rd week
Secondary outcomes (2)
Visual Analogue Scale
Visual Analogue Rating (VAS) is a self-report of clinical pain intensity. The scale was 10 cm long and anchored by the statements "no pain" (0-4 mm) on the left mild pain (5-44 mm), moderate pain (45-74 mm), and the most intense pain imaginable (75-100 mm) on the right. It is a reliable tool with ICC (95% CI) value 0.97 (0.96-0.98). VAS is considered to have good construct validity i.e. highly correlated with numeric rating scale and verbal rating scale with correlations values 0.941 and 0.878 respectively
Measured: 3rd week
Shoulder ranges using Goniometer
A device used by physical therapists to measure joints' range of motion. During measurement fulcrum will be placed on shoulder joint parallel to sagittal axis for abduction and adduction, frontal axis for flexion and extension and to humeral longitudinal axis in 90o of abduction for internal and external rotations. The intra class correlation coefficients (ICC) validity ranged from 0.945 to 0.973 for the goniometric measurements
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2022
- Primary completion15 Jun 2023
- Study completion22 Jun 2023
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PhD*, Principal investigator, Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931666
- Sponsor's protocol ID
- RIPHAH/RCRS/REC/Letter-01400
- Status last verified
- Jul 2023
- First submitted
- 6 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gong and Kaltenborn Mobilization in Frozen Shoulder
- ClinicalTrials.gov ID
- NCT05931666
- Acronym / sponsor ID
- RIPHAH/RCRS/REC/Letter-01400
- Conditions
- Frozen Shoulder
- Keywords
- Gong mobilization, Kaltenborn mobilization, Frozen shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 5 Jul 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 aim of this research is to determine the effects of Gong mobilization and Kaltenborn mobilization in patients of frozen shoulder. This is a Randomized clinical trial. The sample size is 40. The subjects are divided in two groups, with 20 subjects in Group A and 20 subjects in Group B. Study duration is of 6 months. Sampling technique applied is Nonprobability Purposive Sampling. Both males and females of aged 40-65 years with Stage-II frozen shoulder are included. Tools used in the study are Visual Analogue Scale (VAS), Goniometer, and SPADI (Shoulder pain and disability index) questionnaire.
Detailed description
Adhesive capsulitis or periarthritis, more commonly termed as frozen shoulder is a pathological process where adhesions are formed across glenohumeral joint causing debilitating pain and movement restrictions. The pathology is categorized as primary, being idiopathic and occur spontaneously without any inciting event, or secondary which occur as a result of some identifiable disorder such as diabetes mellitus (where a cascade of inflammatory reactions, collagen build-up and other extracellular components lead to tendon fibrosis and dysfunction, presenting as diabetic frozen shoulder) or some other inciting event. The incidence of frozen shoulder is evident to be 3-5% in general population while it's up to 20% in diabetic patients. Further it is more evident in females aged 40-60 years. Moreover frozen shoulder is classified into four stages which include Stage-I characterized by painful shoulder at rest and disturbed sleep, lasting up to 3 months; Stage-II termed the "freezing stage" is identified by chronic pain along with restrictions in range of motion (ROM) and last up to 9 months; Stage-III called the "frozen stage" where a considerable reduction in ROM and a rigid end feel is observed and occurs during 9 to 15 months of onset; Stage-IV is "thawing phase" where ROM improves progressively, as frozen shoulder is a self-limiting condition and lasts from 15 to 24 months.
The standard exercise protocol followed for management of frozen shoulder include active and active assisted exercises, Codman exercises, wall and ladder exercises, wand exercises, capsular stretching, and shoulder joint mobilization. The electrotherapeutic modalities employed include ultrasound to resolve inflammation, interferential therapy and transcutaneous electrical nerve stimulation (TENS) for pain control and thermal therapy to relieve pain and improve muscles extensibility.
Manual therapy techniques of mobilization have been proved to be very effective in treating frozen shoulder. The Gong's mobilization technique which combines the concepts of distraction and Maitland, is explained as end range mobilization where an antero-posterior glide is applied in dynamic position of the shoulder joint followed by distraction and performance of the restricted movement. The technique serves to reduce pain and improve range of motion and is significant in producing immediate effects. Kaltenborn mobilization technique depends on concave rule and gives grades of traction which include loosening, tightening and stretching of the soft connective tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gong Mobilization | Experimental | Other: Gong MobilizationThe subject placed in a side-lying position with the affected shoulder joint facing upward. and abducted at about 90 degrees to maintain the humerus vertical position with elbow in a 90-degree position. The therapist use one hand to keep the subject's elbow joint at 90 degrees, his elbow below the subject's elbow joint, and the other hand to press the humerus head from anterior to posterior. Therapist elevate own body, pulling on the articular capsule of the shoulder joint. This gentle pulling sustained for 10- 15 seconds before relaxing for 5 seconds; the whole manoeuver last roughly 2-3 minutes. |
| Kaltenborn Mobilization | Experimental | Other: Kaltenborn MobilizationPatient lies supine on the table with the arm abducted approximately to 55⁰. The therapist stands facing the lateral side of upper arm. The scapula is fixed using a towel. The therapist's right hand holds around the patients elbow \& forearm from the ventral side. Left hand holds around the humeral head with the thumb ventrally just distal to the acromion \& the direction of movement is towards caudal assisted by therapist's body. Also anterior and posterior glides are applied with patient positioned similarly in supine lying to improve mobility at the shoulder joint. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with unilateral stage-II frozen shoulder.
- Both males and females.
- Subjects within 40- 65 years age.
- Capsular pattern restrictions in ROM (external rotation is more limited than abduction, which is more limited than internal rotation).
Key exclusion criteria (6 listed)
- Subjects with previous surgery of the shoulder joint.
- Subjects with rotator cuff rupture.
- History of recent fracture or severe trauma to the shoulder.
- Restricted shoulder ROM due to burns or postoperative scars.
- Diagnosed instability or previous history of dislocation
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 MobilizationPatients are treated with Gong mobilization protocol along with conventional therapy including ultrasound therapy, hot pack and conventional exercises consisting of codman exercises, ROM exercises and shoulder stabilization exercises. Total of 3 sessions per week for 3 consecutive weeks. | Other | Gong Mobilization |
| Kaltenborn MobilizationPatients are treated with Kaltenborn mobilization protocol along with conventional therapy including ultrasound therapy, hot pack and conventional exercises consisting of codman exercises, ROM exercises and shoulder stabilization exercises. Total of 3 sessions per week for 3 consecutive weeks. | Other | Kaltenborn Mobilization |
Primary outcome
Shoulder pain and disability index
Time frame: 3rd week
SPADI was developed to measure the pain and disability associated with shoulder pathology. The SPADI is a self-administered index consisting of 13 items divided into two subscales i.e. pain and disability. A remarkably good internal consistency and high test-retest reliability value was found (ICC for pain=0.989 [95% CI=0.975-0.995]; ICC for disability=0.990 [95% CI=0.988-0.998]
2 secondary outcomes
Visual Analogue Scale
Time frame: 3rd week
Shoulder ranges using Goniometer
Time frame: 3rd week
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 27 Jul 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.
Muhammad Affan Iqbal, PhD* principal investigator
Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gong Mobilization and Kaltenborn Mobilization in people with Frozen Shoulder, run by Riphah International University at 2 sites 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 6 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Shoulder pain and disability index (time frame: 3rd week). 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 27 Jul 2023.