NCT06110039

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 25, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

shoulder painNECK PAINUPPER THORACIC MOBILIZATIONCERVICOTHORACIC MOBILIZATIONSUBACROMIAL IMPIGEMENT SYNDROME

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    6 weeks

Study Arms (2)

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:

Interventions

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.

Group 1: Cervicothoracic junction mobilization with arm movement along with baseline treatment

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

Group 2: upper thoracic manipulation woth baseline treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranging from 18-40
  • Both males and Females
  • Positive Hawkins and Neer's impingement test positive
  • The subjects primarily report unilateral shoulder pain.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johar pain relief center

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (8)

  • 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.

    PMID: 2078803BACKGROUND
  • Kardouni 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.

    PMID: 25595413BACKGROUND
  • Michener 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.

    PMID: 25261090BACKGROUND
  • McCoy 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.

    PMID: 31754571BACKGROUND
  • McDevitt 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.

    PMID: 26309384BACKGROUND
  • Joshi 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.

    PMID: 32762708BACKGROUND
  • Hunter 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.

    PMID: 35331719BACKGROUND
  • Hegarty 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.

    PMID: 34571486BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder PainNeck Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali raza

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Mehreen Mazhar

    Riphah inernational university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

May 10, 2023

Primary Completion

December 10, 2023

Study Completion

January 10, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations