Adhesive CapsulitisNCT03791892
Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive Capsulitis
A study testing Shoulder mobilization Group and Conventional Treatment Group in people with Adhesive Capsulitis, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Those shoulder patients who fulfill inclusion criteria are divided into two groups. Supervised exercises will be performed by both groups. Kaltenborn mobilization will be applied to patient in experimental group only. Assessment will be done on baseline, 7th and post visit. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Shoulder mobilization Group and Conventional Treatment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Dec 2018to 30 Apr 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 70 years
- Both male and female
- Unilateral cases.
- Grade 1 and 2 phase of adhesive shoulder
Who cannot join
- Traumatic /fracture in upper extremity
- Patients with malignancy
- Post-operative shoulder
- Patient under steroid therapy
- Bilateral cases.
- Grade 3 stage of frozen shoulder.
- Patient with sever osteo-arthritis
- Patient with diabetes
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Imran Amjad
Islamabad, Punjab Province, 46000
Riphah International University
Islamabad, 44000
About this study
Official title: The Effects of Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive
Those shoulder patients who fulfill inclusion criteria are divided into two groups. Supervised exercises will be performed by both groups. Kaltenborn mobilization will be applied to patient in experimental group only. Assessment will be done on baseline, 7th and post visit. A total 38 subjects were included in study who met inclusion criteria. Number of patients in both groups was 19.
Read the detailed description
Adhesive capsulitis is one of the most common debilitating musculoskeletal complaints seen in physiotherapy practice. Adhesive capsulitis is a benign, self-limiting condition of unknown etiology characterized by painful and limited active and passive gleno-humeral range of motion of ≥ 25% in at least two directions most notably shoulder abduction and external rotation. Prevalence of adhesive capsulitis is 2% - 5% in general population.1 Primary adhesive capsulitis and frozen shoulder are current terms used to describe an insidious onset of painful stiffness of the gleno-humeral joint. Secondary adhesive capsulitis, on the other hand, is associated with a known predisposing condition of the shoulder (eg, humerus fracture, shoulder dislocation, avascular necrosis, osteoarthritis, or stroke.
The range of motion (ROM) impairments associated with primary adhesive capsulitis can impact a patient's ability to participate in self-care and occupational activities. Even though this condition is considered self-limiting, with most patients having spontaneous resolution within 3 years, some patients can suffer long-term pain and restricted shoulder motion well beyond 3 years. A disability of this duration places severe emotional and economic hardship on the afflicted person. Most patients are unwilling to suffer this pain, prolonged disability, and sleep deprivation without seeking treatment.
Currently, no standard medical, surgical, or therapy regimen is universally accepted as the most efficacious treatment for restoring motion in patients with shoulder adhesive capsulitis. While physical therapy is commonly prescribed for this condition, some studies have found little treatment benefit. Rehabilitation programs consisting of exercise, massage, and modalities have been shown to improve shoulder ROM in all planes except external and internal rotation. There is evidence, however, that joint mobilization procedures can lessen the associated gleno-humeral rotational deficits characteristic of this condition, especially external rotation. The optimal direction of force and movement application for the joint mobilization to restore external rotation, however, is not clear. Traditionally, physical therapists have used an anterior glide of the humeral head on the glenoid technique to improve external rotation ROM, a choice based on the "convex-on-concave" concept of joint surface motion. In contrast, Roubal et al used a posteriorly directed glide manipulation based on the "capsular constraint mechanism" to restore external as well as internal rotation ROM.Supra-scapular nerve block (SSNB) is a safe and effective method to treat pain in chronic diseases that affect the shoulder. The technique consists of injecting anaesthetics in supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs pending beside the body.The technique consists of injecting anesthetic in supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs pending beside the body.3 In this study keltenborn joint mobilization will be use as intervention is to restore the joint play and in order to normalize the rolling and gliding of any joint, which are necessary for the active normal and non-painful movement. Some general exercises also help us to treat adhesive capsulitis.
- Conditions
- Adhesive Capsulitis
- Being tested
- Shoulder mobilization Group, Conventional Treatment Group
- Keywords
- Adhesive capsulitis, suprascapular nerve, shoulder mobilization
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder mobilization GroupOther
Suprascapular nerve block administered every week to both groups. Joint mobilization (3 sets / 40 seconds hold / 30 seconds interval) Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Strengthening exercises ( 3 sets / 15 reps)
Conventional Treatment GroupOther
Suprascapular nerve block administered every week to both groups. Daily Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Daily Strengthening exercises ( 3 sets / 15 reps)
| Study group | Role | What they receive |
|---|---|---|
| Shoulder mobilization Group | Experimental | Kaltenborn mobilization will be applied to patient in experimental group only. Receives: Other: Shoulder mobilization Group |
| Conventional treatment Group | Active comparator | Application of conventional treatment that includes stretching and strengthening exercises of shoulder. Receives: Other: Conventional Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
NPRS) is a scale used to find the level of pain intensity. At the time of treatment session intensity of pain is mainly the center of attention of the treatment. This pain scale is used in routine in clinical setting during the application of treatment procedure to evaluate the intensity of pain. NPRS has good validity and reliability. In our study we evaluate the status of pain in shoulder in individuals with adhesive capsulitis. The NPRS is a segmented numeric version of the visual analog scale in which a respondent selects the whole number (0-10). '0' indicates no pain whereas '10' indicates extreme pain. In our study NPRS values are taken at base line, 7th visit and post visit
Measured: change from baseline.This tool is used to measure pain intensity
Goniometer
In physical therapy goniometer is utilized to measures range of movement joint angles in the body.
Measured: change from baseline.This tool is used to measure shoulder ranges
Secondary outcomes (1)
SHOULDER PAIN AND DISABILITY INDEX (SPADI)
By using this tool we can access pain as well as level of disability of patient having frozen shoulder. This tool consists of 13 questions. A therapist asked questions to patients. It takes 5 to 10 minutes to finish the questionnaire n marked accordingly. SPADI values were taken at baseline, 7th visit and post visit
Measured: change from baseline.This tool is used to measure shoulder disability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start15 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- imran Amjad, phd*, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791892
- Sponsor's protocol ID
- RiphahI Wajeeha
- Status last verified
- May 2019
- First submitted
- 31 Dec 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39.
PubMed 18475240Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
PubMed 16282408Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.
PubMed 29992159Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
PubMed 20110457Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999 Apr 1;59(7):1843-52.
PubMed 10208704Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
PubMed 16356983Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10.
PubMed 17031613
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive
- ClinicalTrials.gov ID
- NCT03791892
- Acronym / sponsor ID
- RiphahI Wajeeha
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive capsulitis, suprascapular nerve, shoulder mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 3 Jan 2019 (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.
Those shoulder patients who fulfill inclusion criteria are divided into two groups. Supervised exercises will be performed by both groups. Kaltenborn mobilization will be applied to patient in experimental group only. Assessment will be done on baseline, 7th and post visit. A total 38 subjects were included in study who met inclusion criteria. Number of patients in both groups was 19.
Detailed description
Adhesive capsulitis is one of the most common debilitating musculoskeletal complaints seen in physiotherapy practice. Adhesive capsulitis is a benign, self-limiting condition of unknown etiology characterized by painful and limited active and passive gleno-humeral range of motion of ≥ 25% in at least two directions most notably shoulder abduction and external rotation. Prevalence of adhesive capsulitis is 2% - 5% in general population.1 Primary adhesive capsulitis and frozen shoulder are current terms used to describe an insidious onset of painful stiffness of the gleno-humeral joint. Secondary adhesive capsulitis, on the other hand, is associated with a known predisposing condition of the shoulder (eg, humerus fracture, shoulder dislocation, avascular necrosis, osteoarthritis, or stroke.
The range of motion (ROM) impairments associated with primary adhesive capsulitis can impact a patient's ability to participate in self-care and occupational activities. Even though this condition is considered self-limiting, with most patients having spontaneous resolution within 3 years, some patients can suffer long-term pain and restricted shoulder motion well beyond 3 years. A disability of this duration places severe emotional and economic hardship on the afflicted person. Most patients are unwilling to suffer this pain, prolonged disability, and sleep deprivation without seeking treatment.
Currently, no standard medical, surgical, or therapy regimen is universally accepted as the most efficacious treatment for restoring motion in patients with shoulder adhesive capsulitis. While physical therapy is commonly prescribed for this condition, some studies have found little treatment benefit. Rehabilitation programs consisting of exercise, massage, and modalities have been shown to improve shoulder ROM in all planes except external and internal rotation. There is evidence, however, that joint mobilization procedures can lessen the associated gleno-humeral rotational deficits characteristic of this condition, especially external rotation. The optimal direction of force and movement application for the joint mobilization to restore external rotation, however, is not clear. Traditionally, physical therapists have used an anterior glide of the humeral head on the glenoid technique to improve external rotation ROM, a choice based on the "convex-on-concave" concept of joint surface motion. In contrast, Roubal et al used a posteriorly directed glide manipulation based on the "capsular constraint mechanism" to restore external as well as internal rotation ROM.Supra-scapular nerve block (SSNB) is a safe and effective method to treat pain in chronic diseases that affect the shoulder. The technique consists of injecting anaesthetics in supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs pending beside the body.The technique consists of injecting anesthetic in supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs pending beside the body.3 In this study keltenborn joint mobilization will be use as intervention is to restore the joint play and in order to normalize the rolling and gliding of any joint, which are necessary for the active normal and non-painful movement. Some general exercises also help us to treat adhesive capsulitis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental
| Arm | Type | Receives |
|---|---|---|
| Shoulder mobilization Group | Experimental | Other: Shoulder mobilization GroupKaltenborn mobilization will be applied to patient in experimental group only. |
| Conventional treatment Group | Active comparator | Other: Conventional Treatment GroupApplication of conventional treatment that includes stretching and strengthening exercises of shoulder. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40 to 70 years
- Both male and female
- Unilateral cases.
- Grade 1 and 2 phase of adhesive shoulder
Key exclusion criteria (8 listed)
- Traumatic /fracture in upper extremity
- Patients with malignancy
- Post-operative shoulder
- Patient under steroid therapy
- Bilateral cases.
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 |
|---|---|---|
| Shoulder mobilization GroupSuprascapular nerve block administered every week to both groups. Joint mobilization (3 sets / 40 seconds hold / 30 seconds interval) Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Strengthening exercises ( 3 sets / 15 reps) | Other | Shoulder mobilization Group |
| Conventional Treatment GroupSuprascapular nerve block administered every week to both groups. Daily Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Daily Strengthening exercises ( 3 sets / 15 reps) | Other | Conventional treatment Group |
Primary outcome
Numeric Pain Rating Scale
Time frame: change from baseline.This tool is used to measure pain intensity
NPRS) is a scale used to find the level of pain intensity. At the time of treatment session intensity of pain is mainly the center of attention of the treatment. This pain scale is used in routine in clinical setting during the application of treatment procedure to evaluate the intensity of pain. NPRS has good validity and reliability. In our study we evaluate the status of pain in shoulder in individuals with adhesive capsulitis. The NPRS is a segmented numeric version of the visual analog scale in which a respondent selects the whole number (0-10). '0' indicates no pain whereas '10' indicates extreme pain. In our study NPRS values are taken at base line, 7th visit and post visit
Goniometer
Time frame: change from baseline.This tool is used to measure shoulder ranges
In physical therapy goniometer is utilized to measures range of movement joint angles in the body.
1 secondary outcome
SHOULDER PAIN AND DISABILITY INDEX (SPADI)
Time frame: change from baseline.This tool is used to measure shoulder disability
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 May 2019.
- Background: PubMed 18475240Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39.
- Background: PubMed 16282408Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
- Background: PubMed 29992159Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.
- Background: PubMed 20110457Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
- Background: PubMed 10208704Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999 Apr 1;59(7):1843-52.
- Background: PubMed 16356983Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
- Background: PubMed 17031613Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10.
- 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.
imran Amjad, phd* principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder mobilization Group and Conventional Treatment Group in people with Adhesive Capsulitis, 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 8 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 May 2019. 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?
Numeric Pain Rating Scale (time frame: change from baseline.This tool is used to measure pain intensity). 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?
On the ClinicalTrials.gov record for NCT03791892, which also lists 7 linked publications.
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 May 2019.