Subacromial Impingement SyndromeNCT06110039
Comparative Effects of Cervicothoracic Junction Mobilization and Thoracic Manipulation in Subachromial Impinegment Syndrome
A study testing Cervicothoracic Junction Mobilization and Upper Thoracic Spine Manipulation: in people with Subacromial Impingement Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to investigate the comparative effects of high velocity low amplitude thrust manipulation of upper thoracic spine and spinal mobilization with arm movement on the subjects with the subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Cervicothoracic Junction Mobilization and Upper Thoracic Spine Manipulation:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2023to 10 Jan 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranging from 18-40
- Both males and Females
- Positive Hawkins and Neer's impingement test positive
- The subjects primarily report unilateral shoulder pain.
Who cannot join
- Patients with diagnosed case of co morbidities such as malignancies, RA, or fracture, that causes bilateral shoulder discomfort.
- Diagnosed case of cervical radiculopathy, glenohumeral osteoarthritis, and adhesive capsulitis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Johar pain relief center
Lahore, Punjab Province, 54000
Mehreen Mazhar, 03024702918, mehreenmazhar98@gmail.com
Myda tahir, 03371707011, jprc.lahore@gmail.com
About this study
Official title: Comparative Effects of Cervicothoracic Junction Mobilization With Arm Movements and Upper Thoracic Manipulation in Patients With Subachromial Impinegment Syndrome
The aim of this study is to investigate the comparative effects of high velocity low amplitude thrust manipulation of upper thoracic spine and spinal mobilization with arm movement on the subjects with the subacromial impingement syndrome.
Read the detailed description
Subacromial impingement is the condition, in which the tissue underlying subacromial spaces are compressed between the head of the humerus and the acromion, is one ofthe main diagnoses of shoulder pain. Subjects frequently experience pain when engaging in anyoverhead activity.In general, medical practice, pain in the glenohumeral region is commonmusculoskeletal problem has almost 48% prevalence. Cervicothoracic junction refers to atherapeutic technique or manual therapy approaches that focuses on improving mobility andfunction in this area where the cervical neck and upper back spine meet. Upper thoracic manipulation refers to a manual technique used to address dysfunctions or restrictions in the upper portion of the thoracic vertebral region, which is the area of the thoracic vertebrae located between the cervical and mid back regions.Previously, studies were conducted individually to determine effectiveness of upper thoracic mobilization and cervico-thoracic mobilization with arm movement for treatment of subacromial bursitis. However, fewer studies were previously conducted to compare the effects of both treatment methods (mobilization and manipulation). This study specifically focuses on the comparative effects of upper thoracic and cervico-thoracic mobilization.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Cervicothoracic Junction Mobilization, Upper Thoracic Spine Manipulation:
- Keywords
- shoulder pain, NECK PAIN, UPPER THORACIC MOBILIZATION, CERVICOTHORACIC MOBILIZATION, SUBACROMIAL IMPIGEMENT SYNDROME
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervicothoracic Junction MobilizationOther
The therapist stood in back of the subject, who was seated straight on a chair. The therapist positioned the medial side of one hand's thumb. The desired level of vertebra can be strengthened by placing the index finger of the opposite hand on the spinous process. A pure transverse glide was executed from the affected side to the unaffected side.
Upper Thoracic Spine Manipulation:Other
The therapist placed one hand on the patient's head and the hypothenar or thenar eminence of the other hand was placed over the T1 transverse process (the therapist's left hand was used for thrusting and vice versa for treating the left T1 Transverse process). As the tissue deficiency is taken up localizing the forces, the patient was urged to breathe in and out multiple times. While holding the hand on the head steady, a minor relative rotation in the opposite direction was caused, which led to the introduction of the postero-anterior force on the transverse process of T1(29). Patients will receive three sessions a week on alternate days for three weeks and follow up data will be taken once after completion of all three sessions using data collection tools
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cervicothoracic junction mobilization with arm movement along with baseline treatment | Experimental | Not described Receives: Other: Cervicothoracic Junction Mobilization |
| Group 2: upper thoracic manipulation woth baseline treatment | Experimental | Not described Receives: Other: Upper Thoracic Spine Manipulation: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
NPRS scale will be used to quantify pain intensity levels. The scale ranges from '0' for the least amount of pain "no pain" to '10' for the most extreme levels of pain "pain as severe as you can imagine". It is convenient to use NPRS for patients. Its score ranges between 0-10 (19). It is a valid and reliable tool (20).
Reliability ranges from .67-.96 and validity ranges from 0.79-0.95
Measured: 6 weeks
Shoulder pain and disability index SPADI
To quantify the degree to which patients affected with shoulder pain may have disability the Shoulder Pain and Disability Index (SPADI) was created. The SPADI's 13 components are split between a pain scale of five items and a disability scale of eight items. The numerical rating scale variant was created to facilitate its use and scoring (23). Reliability of SPADI is 0.92 and validity is 0.79
Measured: 6 weeks
imagej software
It can calculate area and pixel value statistics of user-defined selections. It can measure distances and angles. It can create density histograms and line profile plots. It supports standard image processing functions such as contrast manipulation, sharpening, smoothing, edge detection and median filtering.. It has been introduced as a reliable assessment tool.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start10 May 2023
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali raza, Principal investigator, Riphah International UniversityMehreen Mazhar, Principal investigator, Riphah inernational university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110039
- Sponsor's protocol ID
- S22C14G30039
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lo YP, Hsu YC, Chan KM. Epidemiology of shoulder impingement in upper arm sports events. Br J Sports Med. 1990 Sep;24(3):173-7. doi: 10.1136/bjsm.24.3.173.
PubMed 2078803Kardouni JR, Shaffer SW, Pidcoe PE, Finucane SD, Cheatham SA, Michener LA. Immediate changes in pressure pain sensitivity after thoracic spinal manipulative therapy in patients with subacromial impingement syndrome: A randomized controlled study. Man Ther. 2015 Aug;20(4):540-6. doi: 10.1016/j.math.2014.12.003. Epub 2014 Dec 22.
PubMed 25595413Michener LA, Kardouni JR, Sousa CO, Ely JM. Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain. Man Ther. 2015 Feb;20(1):171-5. doi: 10.1016/j.math.2014.08.008. Epub 2014 Sep 6.
PubMed 25261090McCoy RC, Bittencourt E, Clifton W. Cervicothoracic Manipulation Techniques Reviewed Utilizing Three-Dimensional Spine Model. Cureus. 2019 Oct 4;11(10):e5836. doi: 10.7759/cureus.5836.
PubMed 31754571McDevitt A, Young J, Mintken P, Cleland J. Regional interdependence and manual therapy directed at the thoracic spine. J Man Manip Ther. 2015 Jul;23(3):139-46. doi: 10.1179/2042618615Y.0000000005.
PubMed 26309384Joshi S, Balthillaya G, Neelapala YVR. Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial. Chiropr Man Therap. 2020 Aug 7;28(1):38. doi: 10.1186/s12998-020-00327-4.
PubMed 32762708Hunter DJ, Rivett DA, McKiernan S, Luton R, Snodgrass SJ. Thoracic Manual Therapy Improves Pain and Disability in Individuals With Shoulder Impingement Syndrome Compared With Placebo: A Randomized Controlled Trial With 1-Year Follow-up. Arch Phys Med Rehabil. 2022 Aug;103(8):1533-1543. doi: 10.1016/j.apmr.2022.03.003. Epub 2022 Mar 21.
PubMed 35331719Hegarty AK, Hsu M, Roy JS, Kardouni JR, Kutch JJ, Michener LA. Evidence for increased neuromuscular drive following spinal manipulation in individuals with subacromial pain syndrome. Clin Biomech (Bristol). 2021 Dec;90:105485. doi: 10.1016/j.clinbiomech.2021.105485. Epub 2021 Sep 21.
PubMed 34571486
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Cervicothoracic Junction Mobilization With Arm Movements and Upper Thoracic Manipulation in Patients With Subachromial Impinegment Syndrome
- ClinicalTrials.gov ID
- NCT06110039
- Acronym / sponsor ID
- S22C14G30039
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- shoulder pain, NECK PAIN, UPPER THORACIC MOBILIZATION, CERVICOTHORACIC MOBILIZATION, SUBACROMIAL IMPIGEMENT SYNDROME
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 31 Oct 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 study is to investigate the comparative effects of high velocity low amplitude thrust manipulation of upper thoracic spine and spinal mobilization with arm movement on the subjects with the subacromial impingement syndrome.
Detailed description
Subacromial impingement is the condition, in which the tissue underlying subacromial spaces are compressed between the head of the humerus and the acromion, is one ofthe main diagnoses of shoulder pain. Subjects frequently experience pain when engaging in anyoverhead activity.In general, medical practice, pain in the glenohumeral region is commonmusculoskeletal problem has almost 48% prevalence. Cervicothoracic junction refers to atherapeutic technique or manual therapy approaches that focuses on improving mobility andfunction in this area where the cervical neck and upper back spine meet. Upper thoracic manipulation refers to a manual technique used to address dysfunctions or restrictions in the upper portion of the thoracic vertebral region, which is the area of the thoracic vertebrae located between the cervical and mid back regions.Previously, studies were conducted individually to determine effectiveness of upper thoracic mobilization and cervico-thoracic mobilization with arm movement for treatment of subacromial bursitis. However, fewer studies were previously conducted to compare the effects of both treatment methods (mobilization and manipulation). This study specifically focuses on the comparative effects of upper thoracic and cervico-thoracic mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cervicothoracic junction mobilization with arm movement along with baseline treatment | Experimental | Other: Cervicothoracic Junction Mobilization |
| Group 2: upper thoracic manipulation woth baseline treatment | Experimental | Other: Upper Thoracic Spine Manipulation: |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranging from 18-40
- Both males and Females
- Positive Hawkins and Neer's impingement test positive
- The subjects primarily report unilateral shoulder pain.
Key exclusion criteria (2 listed)
- Patients with diagnosed case of co morbidities such as malignancies, RA, or fracture, that causes bilateral shoulder discomfort.
- Diagnosed case of cervical radiculopathy, glenohumeral osteoarthritis, and adhesive capsulitis
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 |
|---|---|---|
| Cervicothoracic Junction MobilizationThe therapist stood in back of the subject, who was seated straight on a chair. The therapist positioned the medial side of one hand's thumb. The desired level of vertebra can be strengthened by placing the index finger of the opposite hand on the spinous process. A pure transverse glide was executed from the affected side to the unaffected side. | Other | Group 1: Cervicothoracic junction mobilization with arm movement along with baseline treatment |
| Upper Thoracic Spine Manipulation:The therapist placed one hand on the patient's head and the hypothenar or thenar eminence of the other hand was placed over the T1 transverse process (the therapist's left hand was used for thrusting and vice versa for treating the left T1 Transverse process). As the tissue deficiency is taken up localizing the forces, the patient was urged to breathe in and out multiple times. While holding the hand on the head steady, a minor relative rotation in the opposite direction was caused, which led to the introduction of the postero-anterior force on the transverse process of T1(29). Patients will receive three sessions a week on alternate days for three weeks and follow up data will be taken once after completion of all three sessions using data collection tools | Other | Group 2: upper thoracic manipulation woth baseline treatment |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 6 weeks
NPRS scale will be used to quantify pain intensity levels. The scale ranges from '0' for the least amount of pain "no pain" to '10' for the most extreme levels of pain "pain as severe as you can imagine". It is convenient to use NPRS for patients. Its score ranges between 0-10 (19). It is a valid and reliable tool (20). Reliability ranges from .67-.96 and validity ranges from 0.79-0.95
Shoulder pain and disability index SPADI
Time frame: 6 weeks
To quantify the degree to which patients affected with shoulder pain may have disability the Shoulder Pain and Disability Index (SPADI) was created. The SPADI's 13 components are split between a pain scale of five items and a disability scale of eight items. The numerical rating scale variant was created to facilitate its use and scoring (23). Reliability of SPADI is 0.92 and validity is 0.79
imagej software
Time frame: 6 weeks
It can calculate area and pixel value statistics of user-defined selections. It can measure distances and angles. It can create density histograms and line profile plots. It supports standard image processing functions such as contrast manipulation, sharpening, smoothing, edge detection and median filtering.. It has been introduced as a reliable assessment tool.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 2078803Lo YP, Hsu YC, Chan KM. Epidemiology of shoulder impingement in upper arm sports events. Br J Sports Med. 1990 Sep;24(3):173-7. doi: 10.1136/bjsm.24.3.173.
- Background: PubMed 25595413Kardouni JR, Shaffer SW, Pidcoe PE, Finucane SD, Cheatham SA, Michener LA. Immediate changes in pressure pain sensitivity after thoracic spinal manipulative therapy in patients with subacromial impingement syndrome: A randomized controlled study. Man Ther. 2015 Aug;20(4):540-6. doi: 10.1016/j.math.2014.12.003. Epub 2014 Dec 22.
- Background: PubMed 25261090Michener LA, Kardouni JR, Sousa CO, Ely JM. Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain. Man Ther. 2015 Feb;20(1):171-5. doi: 10.1016/j.math.2014.08.008. Epub 2014 Sep 6.
- Background: PubMed 31754571McCoy RC, Bittencourt E, Clifton W. Cervicothoracic Manipulation Techniques Reviewed Utilizing Three-Dimensional Spine Model. Cureus. 2019 Oct 4;11(10):e5836. doi: 10.7759/cureus.5836.
- Background: PubMed 26309384McDevitt A, Young J, Mintken P, Cleland J. Regional interdependence and manual therapy directed at the thoracic spine. J Man Manip Ther. 2015 Jul;23(3):139-46. doi: 10.1179/2042618615Y.0000000005.
- Background: PubMed 32762708Joshi S, Balthillaya G, Neelapala YVR. Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial. Chiropr Man Therap. 2020 Aug 7;28(1):38. doi: 10.1186/s12998-020-00327-4.
- Background: PubMed 35331719Hunter DJ, Rivett DA, McKiernan S, Luton R, Snodgrass SJ. Thoracic Manual Therapy Improves Pain and Disability in Individuals With Shoulder Impingement Syndrome Compared With Placebo: A Randomized Controlled Trial With 1-Year Follow-up. Arch Phys Med Rehabil. 2022 Aug;103(8):1533-1543. doi: 10.1016/j.apmr.2022.03.003. Epub 2022 Mar 21.
- Background: PubMed 34571486Hegarty AK, Hsu M, Roy JS, Kardouni JR, Kutch JJ, Michener LA. Evidence for increased neuromuscular drive following spinal manipulation in individuals with subacromial pain syndrome. Clin Biomech (Bristol). 2021 Dec;90:105485. doi: 10.1016/j.clinbiomech.2021.105485. Epub 2021 Sep 21.
- 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.
Ali raza principal investigator
Riphah International University
Mehreen Mazhar principal investigator
Riphah inernational university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervicothoracic Junction Mobilization and Upper Thoracic Spine Manipulation: in people with Subacromial Impingement Syndrome, run by Riphah International University at 1 site 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 2 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 31 Oct 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, phd (+923324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 6 weeks). 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 NCT06110039, which also lists 8 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 31 Oct 2023.