Adhesive Capsulitis of ShoulderNCT06449261
Manual Therapy of Spine With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Randomised Clinical Trial
A study testing Spinal Manual therapy used in Physiotherapy Practice in people with Adhesive Capsulitis of Shoulder, run by Gulf Medical University at 2 sites in United Arab Emirates.
Trial summary
Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. Read more about this study
- Who is it for?
- Ages 27 to 70 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Spinal Manual therapy used in Physiotherapy Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 22 Feb 2024to 28 Feb 2025
- 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 27 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with AC \& a Positive for Apley's scratch test.
- Adhesive capsulitis (with symptoms for at least three months and less than 12 months[18]
- Both Gender
- Age 27-70
- Sleep-disturbing night pain
Who cannot join
- Patients who are unwilling to participate
- patients with malignancy
- AC Secondary to fracture and uncontrolled hypertension.
- Unstable cardiac conditions
- Patient with neurological conditions
- Patient with reported concurrent cervical issues
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites, 2 recruiting
- Recruiting
Thumbay Hospital
Ajman, 4184
Praveen Kumar KANDAKURTI, PhD, (+971 6) 7431333 ext. 1386, dean.coahs@gmu.ac.ae
- Recruiting
Sharad
Al Jurf, Ajman Emirate
Watson Arulsingh, PhD
About this study
Official title: C5-C6 and Thoracic Spine Mobilization With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Two-group, Parallel-arm, Single-blinded, Randomized Clinical Trial
Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. This study aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC. The outcome of the study must provide valid information to enhance the prognostic value of adhesive capsulitis.
Read the detailed description
Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neurological control of the shoulder girdle muscles is mainly from cervical roots, particularly from C5/C6 roots, there was not sufficient research to associate this link with AC. Evidence confirms that there is an association between posture and shoulder mobility. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. We aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC.
Methods The protocol is written according to the SPIRIT statement to enhance transparency of content and completeness. Two-group, randomized controlled trial with blinded assessors. A total of 66 adults with AC will be randomly assigned to experimental group to receive C5-C6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. Primary outcomes are Shoulder Pain, range of motion (ROM) of the shoulder joint and Disability Index (SPADI) were to be measured at pre, postintervention following 3 weeks and 3 months..
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Spinal Manual therapy used in Physiotherapy Practice
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manual therapy used in Physiotherapy PracticeOther
C5-C6 and thoracic spine mobilization with postural correction
| Study group | Role | What they receive |
|---|---|---|
| Group receives C5-C6 and thoracic spine mobilization with postural correction | Experimental | The patient will be made to lie in a prone position with the therapist beside her/his height- adjusted couch. Then the therapist who is certified to provide manual therapy will impart grade III+ posterior-to-anterior mobilization/lateral glide according to Maitland class cation focused on the cervical spine, C5-6 segment for 3 bouts of 30 seconds/2 days in a week for 3 weeks. Followed by the patient will be permitted to rest for a few minutes less than 10 minutes before starting the thoracic mobilisation. Thoracic mobilisation will be administered both at central and unilateral postero-anterior passive accessory intervertebral motions (PAIVMs) based on manual therapy evaluation at the thoracic spine. Receives: Other: Spinal Manual therapy used in Physiotherapy Practice |
| Group receives conventional therapy | Active comparator | Controls will receive ultrasound therapy, passive shoulder mobilisation focussed at Glenohumeral joint, self-stretching exercises and patient education by qualified therapist according to clinical practice guidelines while the experimental group underwent spine mobilization with postural correction exercises for 3 weeks. Receives: Other: Spinal Manual therapy used in Physiotherapy Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of shoulder
The smartphone clinometer (Plaincode Software Solutions) is readily available at low cost for several smartphones, including the iPhone, which will be used by all examiners in this study
Measured: 1 Year
SPADY scale
In the original version, the patient was instructed to place a mark on the VAS for each item that best represented their experience of their shoulder problem over the last week [26]. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, a higher score indicating greater impairment or disability.
Measured: 1 Year
Cervical Range of motion
Clinometer app on smartphones is a reliable and valid device for assessing cervical flexion, extension, lateral flexion, and rotation. The results from the study demonstrated moderate to excellent (ICC = .87-.96) concurrent validity in all 6 cervical movements when compared with the universal goniometric measurements
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start22 Feb 2024
- Primary completion20 May 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- 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
- A two-group, parallel-arm, single-blinded, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Watson Arulsingh D R, PhD, Principal investigator, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449261
- Sponsor's protocol ID
- IRB-COHS-FAC-134-MAY-2024
- Status last verified
- Mar 2024
- First submitted
- 11 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arulsingh W, de Sa Ferreira A, Kandakurti PK, Patil SS. C5-C6 and thoracic spine mobilization with postural correction exercise compared with conventional therapy in patients with adhesive capsulitis: a two-group, parallel-arm, single-blinded, randomized clinical trial-study protocol. Trials. 2026 Apr 13;27(1):378. doi: 10.1186/s13063-026-09690-8.
PubMed 41975488
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C5-C6 and Thoracic Spine Mobilization With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Two-group, Parallel-arm, Single-blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06449261
- Acronym / sponsor ID
- IRB-COHS-FAC-134-MAY-2024
- Conditions
- Adhesive Capsulitis of Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 7 Jun 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.
Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. This study aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC. The outcome of the study must provide valid information to enhance the prognostic value of adhesive capsulitis.
Detailed description
Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neurological control of the shoulder girdle muscles is mainly from cervical roots, particularly from C5/C6 roots, there was not sufficient research to associate this link with AC. Evidence confirms that there is an association between posture and shoulder mobility. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. We aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC.
Methods The protocol is written according to the SPIRIT statement to enhance transparency of content and completeness. Two-group, randomized controlled trial with blinded assessors. A total of 66 adults with AC will be randomly assigned to experimental group to receive C5-C6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. Primary outcomes are Shoulder Pain, range of motion (ROM) of the shoulder joint and Disability Index (SPADI) were to be measured at pre, postintervention following 3 weeks and 3 months..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A two-group, parallel-arm, single-blinded, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group receives C5-C6 and thoracic spine mobilization with postural correction | Experimental | Other: Spinal Manual therapy used in Physiotherapy PracticeThe patient will be made to lie in a prone position with the therapist beside her/his height- adjusted couch. Then the therapist who is certified to provide manual therapy will impart grade III+ posterior-to-anterior mobilization/lateral glide according to Maitland class cation focused on the cervical spine, C5-6 segment for 3 bouts of 30 seconds/2 days in a week for 3 weeks. Followed by the patient will be permitted to rest for a few minutes less than 10 minutes before starting the thoracic mobilisation. Thoracic mobilisation will be administered both at central and unilateral postero-anterior passive accessory intervertebral motions (PAIVMs) based on manual therapy evaluation at the thoracic spine. |
| Group receives conventional therapy | Active comparator | Other: Spinal Manual therapy used in Physiotherapy PracticeControls will receive ultrasound therapy, passive shoulder mobilisation focussed at Glenohumeral joint, self-stretching exercises and patient education by qualified therapist according to clinical practice guidelines while the experimental group underwent spine mobilization with postural correction exercises for 3 weeks. |
Who may qualify
- Ages
- 27 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with AC \& a Positive for Apley's scratch test.
- Adhesive capsulitis (with symptoms for at least three months and less than 12 months[18]
- Both Gender
- Age 27-70
- Sleep-disturbing night pain
Key exclusion criteria (6 listed)
- Patients who are unwilling to participate
- patients with malignancy
- AC Secondary to fracture and uncontrolled hypertension.
- Unstable cardiac conditions
- Patient with neurological conditions
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 |
|---|---|---|
| Spinal Manual therapy used in Physiotherapy PracticeC5-C6 and thoracic spine mobilization with postural correction | Other | Group receives C5-C6 and thoracic spine mobilization with postural correction, Group receives conventional therapy |
Primary outcome
Range of motion of shoulder
Time frame: 1 Year
The smartphone clinometer (Plaincode Software Solutions) is readily available at low cost for several smartphones, including the iPhone, which will be used by all examiners in this study
SPADY scale
Time frame: 1 Year
In the original version, the patient was instructed to place a mark on the VAS for each item that best represented their experience of their shoulder problem over the last week [26]. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, a higher score indicating greater impairment or disability.
Cervical Range of motion
Time frame: 1 Year
Clinometer app on smartphones is a reliable and valid device for assessing cervical flexion, extension, lateral flexion, and rotation. The results from the study demonstrated moderate to excellent (ICC = .87-.96) concurrent validity in all 6 cervical movements when compared with the universal goniometric measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 41975488Arulsingh W, de Sa Ferreira A, Kandakurti PK, Patil SS. C5-C6 and thoracic spine mobilization with postural correction exercise compared with conventional therapy in patients with adhesive capsulitis: a two-group, parallel-arm, single-blinded, randomized clinical trial-study protocol. Trials. 2026 Apr 13;27(1):378. doi: 10.1186/s13063-026-09690-8.
- 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.
Watson Arulsingh D R, PhD principal investigator
Gulf Medical 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 Spinal Manual therapy used in Physiotherapy Practice in people with Adhesive Capsulitis of Shoulder, run by Gulf Medical University at 2 sites in United Arab Emirates.
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 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. 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 United Arab Emirates. 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 Watson Arulsingh D R, PhD (+971505708763, dr.watson@gmu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of shoulder (time frame: 1 Year). 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?
On the ClinicalTrials.gov record for NCT06449261, which also lists 1 linked publication.
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 7 Jun 2024.