Protocol summary
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Study aim
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the aim of this study is to investigate the effect of dry needling on the trigger points of the subscapularis muscle and to improve the clinical symptoms of people with frozen shoulder.
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Design
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Randomized clinical trial with the control group, with parallel groups, single-blinded, on 40 patients, randomization allocation software will be used for randomization.
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Settings and conduct
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Patients randomly will be divided into two groups. The first group (intervention group) will receive dry needling of the subscapularis muscle during 3 sessions. At the same time, They also benefit from conventional physiotherapy treatment, but the control group will only use conventional physiotherapy treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
subjects were diagnosed with frozen shoulder .
the presence of active trigger points in the subscapularis muscle
Exclusion criteria:
needle phobia
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Intervention groups
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The intervention group consists of patients with frozen shoulder.
Routine physiotherapy includes Continuous ultrasound with a frequency of 3 MHz for 6 minutes, high-intensity electric current with a frequency of 100 Hz and diversion of 20 minutes, hot pack simultaneously with the application of the current. Postero-anterior, Antero-posterior and caudal glides. The shoulder muscles stretching and active-assistive exercises using a towel as well. They also will receive 3 sessions of dry needling.
The control group consists of patients with frozen shoulder who will only receive routine physiotherapy.
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Main outcome variables
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Shoulder range of motion; intensity of pain in trigger points of the subscapularis muscles and shoulder joint; Pain pressure threshold of trigger points; Upper limb functional disability
General information
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Reason for update
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Change the end date of data collection
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200215046499N3
Registration date:
2023-04-25, 1402/02/05
Registration timing:
prospective
Last update:
2026-06-26, 1405/04/05
Update count:
1
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Registration date
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2023-04-25, 1402/02/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-20, 1402/03/30
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Expected recruitment end date
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2024-12-10, 1403/09/20
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Actual recruitment start date
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2023-06-20, 1402/03/30
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Actual recruitment end date
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2024-12-10, 1403/09/20
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Trial completion date
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empty
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Scientific title
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Effects of dry needling on subscapularis and conventional physiotherapy on clinical symptom improvement in people with frozen shoulder
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Public title
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Effects of dry needling and physiotherapy in patients with frozen shoulder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Those who have been diagnosed with frozen shoulder by a doctor and have symptoms such as pain and reduced range of motion in the capsular pattern in the shoulder joint for 3 months or more
age between 35 and 65 years old
the presence of active trigger points in the subscapularis muscle on the involved side
Pain intensity of at least 3 out of 10 in the VAS
Exclusion criteria:
skin problems in the neck and shoulder area
Antiplatelet therapy has been used in the three days before the start of the study
In the six months before starting the study, they had a history of cancer and related pain in the shoulder and pectoral region
In the three months before the start of the study, they used corticosteroid injections in the shoulder area
needle fobia
Non-cooperation during treatment
Shoulder arthroscopy surgery
cervical radiculopathy or any neurological injury in upper limb
Patients with rheumatoid or neurological diseases
Patients who use pace makers
Patients with positive subacromial entrapment tests
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Age
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From 35 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization with a sealed envelope: Two envelopes are prepared with the first and second group titles. Each participant randomly selects one envelope and the envelope number is recorded for the participant. The envelopes are then merged and the next participant selects another envelope from the two envelopes as the previous procedure to complete the randomization process in both groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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evaluator is blind to the type of intervention in each group
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-06, 1401/12/15
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Ethics committee reference number
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IR.TBZMED.REC.1402.013
Health conditions studied
1
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Description of health condition studied
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frozen shoulder
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ICD-10 code
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M75.00
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ICD-10 code description
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Adhesive capsulitis of unspecified shoulder
Primary outcomes
1
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Description
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Range of motion of shoulder joint
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Timepoint
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before and after intervention
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Method of measurement
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goniometer
Secondary outcomes
1
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Description
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pain intensity of trigger point
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Timepoint
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before and after intervention
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Method of measurement
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Visual analog scale
2
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Description
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pain intensity of shoulder joint
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Timepoint
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before and after intervention
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Method of measurement
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visual analog scale (VAS)
3
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Description
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Pain pressure threshold of trigger points
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Timepoint
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before and after intervention
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Method of measurement
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algometer
4
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Description
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Upper limb functional disability
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Timepoint
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at first, fifth and tenth of treatment sessions
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Method of measurement
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disability of arm, shoulder and hand (DASH)
Intervention groups
1
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Description
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Intervention group: In addition to receiving the subscapularis dry needling during 3 sessions (in the 3rd, 6th, and 9th sessions of treatment) with a sterile dong bang needle with a size of 30*50 mm, the patient receives conventional physiotherapy treatment provided by the physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with a speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day.
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Category
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Rehabilitation
2
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Description
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Control group: People in this group only will receive conventional physiotherapy treatment provided by a physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tabriz university of medical sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available