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Adhesive CapsulitisRCTNCT06664437

Efficacy of Adding Neural Mobilization to Joint Mobilization in Patients With Adhesive Capsulitis

A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Adhesive Capsulitis, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Adhesive capsulitis (AC) is a common musculoskeletal disorder affecting the functional activities of daily living through capsular restriction. There is a limited knowledge concerning neural restriction as a source of movement limitation in patients with AC other than the enriched knowledge regarding joint… 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?
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSaudi Arabia
Study dates
1 May 2024to 1 Sep 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients from both genders were included in this study if they would have primary AC with their ages between 40 and 70 years old and complained of pain, stiffness, and limitation of passive shoulder lateral rotation, abduction, and internal rotation of greater than 50%compared to the non-affected side for at least 3 months. Patients with positive (ULTT-1) were also included in this study .

Who cannot join

  • Patients were excluded if they would have stroke, Parkinson's diseases that interfere with shoulder muscles activity, diabetes, traumatic shoulder conditions, glenohumeral osteoarthritis confirmed by x-ray, previous surgery and manipulation under anesthesia of the affected shoulder. Patients with restricted passive elbow extension ROM were also excluded.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Prince Sattam bin Abdulaziz University

    Riyadh, Alkharj, 11942

Other trials in Saudi Arabia

About this study

Background: Adhesive capsulitis (AC) is a common musculoskeletal disorder affecting the functional activities of daily living through capsular restriction. There is a limited knowledge concerning neural restriction as a source of movement limitation in patients with AC other than the enriched knowledge regarding joint mobilization techniques in addressing mobility restrictions for patients with AC. Objectives: This study was designed to determine the efficacy of adding median nerve mobilization to the glenohumeral (GH) joint mobilization techniques on shoulder pain intensity, functional disability and active and passive ROM of glenohumeral abduction and external rotation in patients with AC. Methods: Thirty patients with primary AC with their ages ranged from 40 to 70 years old were included and randomly assigned into two groups. Group A received GH joint mobilization techniques while patients in group B received median nerve mobilization in addition to GH joint mobilization. Both groups received conventional physical therapy which included hot pack for 10 minutes, pendulum exercise and stretching exercises. Treatment sessions were three per week for six weeks. Patients were assessed pre and post interventional procedures for shoulder pain intensity by visual analogue scale (VAS), functional disability by shoulder pain and disability index (SPADI) and active and passive ROM of GH abduction and external rotation by conventional goniometer

Read the detailed description

Methods:

Study Design: a randomized single blinded controlled trial. This study was conducted at the outpatient clinic of physical therapy, department of rehabilitation and health sciences, college of applied medical sciences, Prince Sattam bin Abdulaziz University over a period from to April to septemper 2024.

Sample size calculation:

Sample size calculation was carried out using g power statistical analysis software (version 3.1.9.2) and revealed that the required size of each group was 26. This calculation was made using α level of 0.05, β=0.2 and large effect size =0.8. Sample size included 20% more than that calculated in anticipation of withdrawal from the experiment (30 in each group). Calculation also based on post treatment data of external ROM measurements from a previous study done by Jung et al

Patients:

Patients were recruited from nearby hospitals and health care facilities and through personal contacts in Al-Kharj city. Ethical approval was granted by the institutional human ethical committee (NO.RHPT/024/007), and patients who agreed to participate signed a written informed consent in accordance with the declaration of Helsinki.

Thirty patients were randomly assigned int 2 groups. Group A(n=15) received oscillatory GH posterior and inferior glide while patients in group B (n=15) received median nerve mobilization (ULLT-1) in addition to GH joint mobilization. All patients in both groups received traditional physical therapy which included hot pack for 10-15 minutes, pendulum exercises and stretching exercises. Patients received three sessions per week for six week and they were evaluated pre and post treatment for shoulder pain intensity by visual analogue scale, functional disability by Shoulder pain and disability index (SPADI) and active and passive ROM of GH abduction and external rotation by conventional goniometer.

Inclusion criteria:

Patients from both genders were included in this study if they would have primary AC with their ages between 40 and 70 years old and complained of pain, stiffness, and limitation of passive shoulder lateral rotation, abduction, and internal rotation of greater than 50%compared to the non-affected side for at least 3 months. Patients with positive (ULTT-1) were also included in this study .

Exclusion criteria:

Patients were excluded if they would have stroke, Parkinson's diseases that interfere with shoulder muscles activity, diabetes, traumatic shoulder conditions, glenohumeral osteoarthritis confirmed by x-ray, previous surgery and manipulation under anesthesia of the affected shoulder [39]. Patients with restricted passive elbow extension ROM were also excluded.

Methods:

Assessment of shoulder pain intensity:

Assessment of shoulder pain intensity was measured by visual analogue scale (VAS) [40] which consists of a horizontal line from 0 to 10 where zero end refers to no pain while the other end refers to great pain. It is a reliable test for literate and illiterate patients 0.94,0.71 respectively) . The patient was asked to mark a point on the line of VAS that represents his or her pain severity. The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked . The obtained score was recorded and was used for statistical analysis .

Assessment of shoulder functional disability:

Shoulder Pain and Disability Index (SPADI) which is a self-questionnaire was used to assess the shoulder pain severity and its influence on functional abilities and activities of daily. Two subscales are included: "Pain" and "Disability". The "Pain" subscale determines the intensity and frequency of glenohumeral pain. In contrast, the "Disability" subscale assesses the impact of pain on activities of daily living, such as self-care, work, and recreational activities. Each subscale involves various factors rated on a Likert scale, where patients experience pain or difficulty. The overall SPADI score was calculated after adding the results of each subscale together. The lowest score is 0 while 100 is the highest score which means that greater grade of pain and functional disability.

Assessment of shoulder ROM:

Conventional goniometer was used to assess active and passive shoulder ROM. It is a highly reliable method (0.94-0.98 test-retest reliability. Patients in this study were assessed for active and passive ROM of glenohumeral abduction and external rotation (with the arm at 0 degrees of abduction) . All Measurements of shoulder ROM were performed three times, and the mean values were used for the statistical analysis

Assessment of GH abduction and external rotation ROM:

For measurement of GH abduction ROM, the patient was in supine lying with shoulder in neutral position; the therapist aligned the fulcrum of the goniometer at the anterior acromial aspect and the movable arm along the anterior aspect of the humerus and the stationary arm was parallel to midline of sternum, the patient was asked to actively elevate his arm in abduction as much as he could, and the reading of the goniometer was noted and was recorded after taking the average of three trials. The passive ROM was performed with the same maneuver but the therapist himself raised the patient's shoulder in abduction through the available range the patient could reach .

For measurement of GH external rotation, the patient was in supine lying with the arm 90 degree abducted and 90-degree elbow flexed. The fulcrum of the goniometer was placed over the olecranon process, the stationary arm was perpendicular to floor, and the movable arm was parallel to the axis ulnar shaft. The patient was asked to actively rotate the arm externally as much as possible, and the reading of the goniometer was noted and was recorded after taking the average of three trials. The passive ROM was performed with the same maneuver but the therapist himself passively rotated the patient's arm externally through the available range the patient could reach

.Interventional procedures: Group (A): GH Joint mobilization techniques (Posterior, Inferior glide). Patients were in supine lying position during the whole treatment. The techniques were performed in a rhythmic way, with 2 seconds of glide distraction and then a 2-second break. Each technique was done for 2 minutes [36]. Posterior gliding was performed by maintaining lateral humeral distraction with the glenohumeral in abduction range and the scapula stabilized. Then the therapist applied posterior glide in an oscillating manner. For inferior gliding, with the scapula stabilized, the therapist maintained lateral humeral distraction while applying inferior glide in the resting position of the glenohumeral joint. Patients had 3 sessions of joint mobilization per week for 6 weeks.

Group (B): Median nerve mobilization techniques (ULLT-1) in addition to GH joint mobilization

Patients also in this group remained in supine lying position. Median nerve mobilization was performed by placing the scapula in a depressed position with one hand while placing the elbow in 90° flexion, forearm in supination, and wrist and fingers in extension with the other hand. Then, the therapist passively abducted the shoulder into 90- 100° and available external rotation ROM of the arm. Then from this position, the therapist extended the elbow with or without contra lateral side bending of the neck (tensioner or slider technique, respectively). Patients performed 30 repetitions of slider median nerve mobilization by performing elbow extension and wrist extension, with the neck placed in ipsilateral side bending or performing elbow flexion and wrist flexion with the neck placed in contralateral side bending. [35]. Tensioner technique was performed by applying simultaneous elbow extension with contralateral side bending of the neck and hold for 15 sec and relax for 10 sec .

Patients in both groups had traditional physical therapy which included 15-20 minutes of hot pack placed under the axilla before mobilization and pendulum exercises to relax and reduce the tension of the glenohumeral muscles . In addition to that, stretching exercises for glenohumeral muscles in the direction of forward elevation, external rotation, horizontal adduction and internal rotation were performed three times per day with holding for 1-5 sec .

Statistical analysis Results were statistically analyzed using SPSS 21, Windows version. All data were expressed as mean ± SD. The Shapiro-Wilk test was used to calculate the normal distribution of scores. For between-group comparison, the independent t-test was used dependent t-test was used for within group comparison.

Being tested
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Keywords
Adhesive capsulitis, Shoulder disability, Joint mobilization
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther

    Also called joint mobilization

    Patients were in supine lying position during the whole treatment. The techniques were performed in a rhythmic way, with 2 seconds of glide distraction and then a 2-second break. Each technique was done for 2 minutes [36]. Posterior gliding was performed by maintaining lateral humeral distraction with the glenohumeral in abduction range and the scapula stabilized. Then the therapist applied posterior glide in an oscillating manner. For inferior gliding, with the scapula stabilized, the therapist maintained lateral humeral distraction while applying inferior glide in the resting position of the glenohumeral joint. Patients had 3 sessions of joint mobilization per week for 6 weeks.

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther

    Patients also in this group remained in supine lying position. Median nerve mobilization was performed by placing the scapula in a depressed position with one hand while placing the elbow in 90° flexion, forearm in supination, and wrist and fingers in extension with the other hand. Then, the therapist passively abducted the shoulder into 90- 100° and available external rotation ROM of the arm. Then from this position, the therapist extended the elbow with or without contra lateral side bending of the neck (tensioner or slider technique, respectively). Patients performed 30 repetitions of slider median nerve mobilization by performing elbow extension and wrist extension, with the neck placed in ipsilateral side bending or performing elbow flexion and wrist flexion with the neck placed in contralateral side bending. [35]. Tensioner technique was performed by applying simultaneous elbow extension with contralateral side bending of the neck and hold for 15 sec and relax for 10 sec .

Study groups in NCT06664437
Study groupRoleWhat they receive
group AExperimentalGroup (A): GH Joint mobilization techniques (Posterior, Inferior glide). Patients were in supine lying position during the whole treatment. The techniques were performed in a rhythmic way, with 2 seconds of glide distraction and then a 2-second break. Each technique was done for 2 minutes [36]. Posterior gliding was performed by maintaining lateral humeral distraction with the glenohumeral in abduction range and the scapula stabilized. Then the therapist applied posterior glide in an oscillating manner. For inferior gliding, with the scapula stabilized, the therapist maintained lateral humeral distraction while applying inferior glide in the resting position of the glenohumeral joint. Patients had 3 sessions of joint mobilization per week for 6 weeks.
Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Group (B)ExperimentalMedian nerve mobilization techniques (ULLT-1) in addition to GH joint mobilization
Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. glnohumeral ROM

    Assessment of shoulder ROM:

    Conventional goniometer was used to assess active and passive shoulder ROM. It is a highly reliable method (0.94-0.98 test-retest reliability. Patients in this study were assessed for active and passive ROM of glenohumeral abduction and external rotation (with the arm at 0 degrees of abduction) . All Measurements of shoulder ROM were performed three times, and the mean values were used for the statistical analysis

    Assessment of GH abduction and external rotation ROM:

    For measurement of GH abduction ROM, the patient was in supine lying with shoulder in neutral position; the therapist aligned the fulcrum of the goniometer at the anterior acromial aspect and the movable arm along the anterior aspect of the humerus and the stationary arm was parallel to midline of sternum, the patient was asked to actively elevate his arm in abduction as much as he could, and the reading of the goniometer was noted and was recorded after taking the average of three trials. T

    Measured: At baseline and after 6 weeks

Secondary outcomes (2)
  1. glenohumeral disability

    Assessment of shoulder functional disability:

    Shoulder Pain and Disability Index (SPADI) which is a self-questionnaire was used to assess the shoulder pain severity and its influence on functional abilities and activities of daily. Two subscales are included: "Pain" and "Disability". The "Pain" subscale determines the intensity and frequency of glenohumeral pa

    Measured: At baseline and after 6 weeks

  2. glenohumeral pain intensity

    Assessment of shoulder pain intensity:

    Assessment of shoulder pain intensity was measured by visual analogue scale (VAS) [40] which consists of a horizontal line from 0 to 10 where zero end refers to no pain while the other end refers to great pain. It is a reliable test for literate and illiterate patients 0.94,0.71 respectively) . The patient was asked to mark a point on the line of VAS that represents his or her pain severity. The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked . The obtained score was recorded and was used for statistical analysis .

    Measured: At baseline and after 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start1 May 2024
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2024

Resources

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
Interventional procedures: Group (A): GH Joint mobilization techniques (Posterior, Inferior glide). Patients were in supine lying position during the whole treatment. The techniques were performed in a rhythmic way, with 2 seconds of glide distraction and then a 2-second break. Each technique was done for 2 minutes \[36\]. Posterior gliding was performed by maintaining lateral humeral distraction with the glenohumeral in abduction range and the scapula stabilized. Then the therapist applied posterior glide in an oscillating manner. For inferior gliding, with the scapula stabilized, the therapist maintained lateral humeral distraction while applying inferior glide in the resting position of the glenohumeral joint. Patients had 3 sessions of joint mobilization per week for 6 weeks. Group (B): Median nerve mobilization techniques (ULLT-1) in addition to GH joint mobilization Patients also in this group remained in supine lying position. Median nerve mobilization was performed by placin
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06664437
Sponsor's protocol ID
SCBR-353/2024
Other IDs
2024/03/29095
Acronym
RCT
Status last verified
Oct 2024
First submitted
27 Oct 2024
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No need

Publications

  • Yang JL, Chang CW, Chen SY, Wang SF, Lin JJ. Mobilization techniques in subjects with frozen shoulder syndrome: randomized multiple-treatment trial. Phys Ther. 2007 Oct;87(10):1307-15. doi: 10.2522/ptj.20060295. Epub 2007 Aug 7.

    PubMed 17684085
  • Schmid AB, Brunner F, Luomajoki H, Held U, Bachmann LM, Kunzer S, Coppieters MW. Reliability of clinical tests to evaluate nerve function and mechanosensitivity of the upper limb peripheral nervous system. BMC Musculoskelet Disord. 2009 Jan 21;10:11. doi: 10.1186/1471-2474-10-11.

    PubMed 19154625
  • Akhtar M, Karimi H, Gilani SA, Ahmad A, Raza A. The effectiveness of routine physiotherapy with and without neuromobilization on pain and functional disability in patients with shoulder impingement syndrome; a randomized control clinical trial. BMC Musculoskelet Disord. 2020 Nov 21;21(1):770. doi: 10.1186/s12891-020-03787-0.

    PubMed 33220710
  • Joshi D, Shah S, Shinde SB, Patil S. Effect of Neural Tissue Mobilization on Sensory-Motor Impairments in Breast Cancer Survivors with Lymphedema: An Experimental Study. Asian Pac J Cancer Prev. 2023 Jan 1;24(1):313-319. doi: 10.31557/APJCP.2023.24.1.313.

    PubMed 36708582
  • Hegazy MMA, Alrawaili SM, El Negamy TE, Rizk FM. The Added Value of Neural Mobilization Techniques to Proprioceptive Neuromuscular Facilitation in Patients With Adhesive Capsulitis: Randomized Controlled Trial. Physiother Res Int. 2026 Oct;31(4):e70350. doi: 10.1002/pri.70350.

    PubMed 42750164
  • Hegazy MMA, Mahmoud WSE, Ahmed AS. Slider Versus Tensioner Median Nerve Mobilization in Patients With Frozen Shoulder Randomized Controlled Comparative Study. Physiother Res Int. 2026 Jan;31(1):e70164. doi: 10.1002/pri.70164.

    PubMed 41549328

Questions about this trial

What is this clinical trial studying?

A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Adhesive Capsulitis, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.

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 1 inclusion and 1 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 29 Oct 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 Saudi Arabia. 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?

glnohumeral ROM (time frame: At baseline and after 6 weeks). 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 NCT06664437, which also lists 6 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 29 Oct 2024.

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