NCT04619173

Brief Summary

The aim of this study is to measure the additional effects of thoracic manipulation on pain and restricted shoulder mobility and reducing disability in patients with adhesive capsulitis. A randomized control trail is conducting at Helping hand institute of rehabilitation sciences Mansehra. Patients diagnosed with frozen shoulder were randomized into 2 groups i.e. Group A (n=16) and Group B(n=16) with the help of lottery method. Group A would receive conventional therapy including hot pack, transcutaneous electrical nerve stimulation, stretches and facilitation techniques Group B would receive thoracic manipulation along with hot pack and TENS, stretches and facilitation techniques. The total treatment time is 2 weeks with three sessions per week making a total of 6 sessions. Baseline assessment on 1st visit. 2nd assessment on 6th visit. 3rd assessment on follow up after 3 weeks would be done. The study duration is 6 months. Purposive non probability sampling technique applied. Only 40 to 60 years participants with adhesive capsulitis are including in this trial. Tools use in this study are visual analogue scale (VAS), bubble inclinometer and (disability of arm, shoulder and hand) questionnaire. Data analyzed through statistical package of social sciences version 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

November 1, 2020

Last Update Submit

December 12, 2024

Conditions

Keywords

Frozen ShoulderThoracic Manipulation

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale (VAS):

    Visual analogue scale is a simple and frequently used method for the assessment of variations in intensity of pain. The VAS consists of a 10cm horizontal line with the words "no pain" and "worst pain" at the line's end. VAS is a reliable and valid tool to reliable and valid tool to measure pain intensity measure pain intensity. Changes from the baseline will be measured and at 4th week and then at 6th week

    3 weeks

  • Bubble Inclinometer

    Bubble Inclinometer is used to measure range-of-motion (ROM).

    3 weeks

  • (Disabilities of the Arm, Shoulder and Hand) questionnaire:

    The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb.

    3 weeks

Study Arms (2)

Thoracic manipulation

EXPERIMENTAL

additional thoracic manipulation along with hotpack, transcutaneous electrical nerve stimulation ,serratus anterior,pectoralis major,minor, posterior capsular stretches..

Other: Thoracic manipulation

Conventional Physical Therapy Program

ACTIVE COMPARATOR

hot pack transcutaneous electrical nerve stimulation, serratus,anterior,pectoralis major, minor, posterior capsular stretches.

Other: Conventional physical therapy Program

Interventions

hot pack ,transcutaneous electrical nerve stimulation and manipulation along with stretching'

Thoracic manipulation

hot pack ,transcutaneous electrical nerve stimulation and stretching

Conventional Physical Therapy Program

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adhesive capsulitis (Stage II and III)
  • Bilateral or unilateral involvement
  • Thoracic spine hypomobility

You may not qualify if:

  • Any previous Surgery on the affected shoulder.
  • Recent trauma to shoulder complex.
  • Thoracic outlet syndrome.
  • Cervical symptoms (tingling, numbness).
  • Rotator cuff tears of affected shoulder.
  • Fractures involving shoulder complex.
  • Osteoporosis of spine.
  • Ankylosing spondylitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hand Institute of Rehabilitation Sciences

Mānsehra, KPK, 21300, Pakistan

Location

Related Publications (16)

  • Uppal HS, Evans JP, Smith C. Frozen shoulder: A systematic review of therapeutic options. World J Orthop. 2015 Mar 18;6(2):263-8. doi: 10.5312/wjo.v6.i2.263. eCollection 2015 Mar 18.

    PMID: 25793166BACKGROUND
  • Riley SP, Bialosky J, Cote MP, Swanson BT, Tafuto V, Sizer PS, Brismee JM. Thoracic spinal manipulation for musculoskeletal shoulder pain: Can an instructional set change patient expectation and outcome? Man Ther. 2015 Jun;20(3):469-74. doi: 10.1016/j.math.2014.11.011. Epub 2014 Dec 2.

    PMID: 25543999BACKGROUND
  • Kebaetse M, McClure P, Pratt NA. Thoracic position effect on shoulder range of motion, strength, and three-dimensional scapular kinematics. Arch Phys Med Rehabil. 1999 Aug;80(8):945-50. doi: 10.1016/s0003-9993(99)90088-6.

    PMID: 10453773BACKGROUND
  • Walser RF, Meserve BB, Boucher TR. The effectiveness of thoracic spine manipulation for the management of musculoskeletal conditions: a systematic review and meta-analysis of randomized clinical trials. J Man Manip Ther. 2009;17(4):237-46. doi: 10.1179/106698109791352085.

    PMID: 20140155BACKGROUND
  • Peek AL, Miller C, Heneghan NR. Thoracic manual therapy in the management of non-specific shoulder pain: a systematic review. J Man Manip Ther. 2015 Sep;23(4):176-87. doi: 10.1179/2042618615Y.0000000003.

    PMID: 26917935BACKGROUND
  • Boyles RE, Ritland BM, Miracle BM, Barclay DM, Faul MS, Moore JH, Koppenhaver SL, Wainner RS. The short-term effects of thoracic spine thrust manipulation on patients with shoulder impingement syndrome. Man Ther. 2009 Aug;14(4):375-80. doi: 10.1016/j.math.2008.05.005. Epub 2008 Aug 15.

    PMID: 18703377BACKGROUND
  • Alptekin HK, Aydin T, Iflazoglu ES, Alkan M. Evaluating the effectiveness of frozen shoulder treatment on the right and left sides. J Phys Ther Sci. 2016 Jan;28(1):207-12. doi: 10.1589/jpts.28.207. Epub 2016 Jan 30.

    PMID: 26957759BACKGROUND
  • Kraal T, The B, Boer R, van den Borne MP, Koenraadt K, Goossens P, Eygendaal D. Manipulation under anesthesia versus physiotherapy treatment in stage two of a frozen shoulder: a study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Oct 11;18(1):412. doi: 10.1186/s12891-017-1763-2.

    PMID: 29020962BACKGROUND
  • Eljabu W, Klinger HM, von Knoch M. Prognostic factors and therapeutic options for treatment of frozen shoulder: a systematic review. Arch Orthop Trauma Surg. 2016 Jan;136(1):1-7. doi: 10.1007/s00402-015-2341-4. Epub 2015 Oct 17.

    PMID: 26476720BACKGROUND
  • Wu WT, Chang KV, Han DS, Chang CH, Yang FS, Lin CP. Effectiveness of Glenohumeral Joint Dilatation for Treatment of Frozen Shoulder: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Sci Rep. 2017 Sep 5;7(1):10507. doi: 10.1038/s41598-017-10895-w.

    PMID: 28874727BACKGROUND
  • Cao DZ, Wang CL, Qing Z, Liu LD. Effectiveness of extracorporeal shock-wave therapy for frozen shoulder: A protocol for a systematic review of randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14506. doi: 10.1097/MD.0000000000014506.

    PMID: 30762780BACKGROUND
  • McClure P, Balaicuis J, Heiland D, Broersma ME, Thorndike CK, Wood A. A randomized controlled comparison of stretching procedures for posterior shoulder tightness. J Orthop Sports Phys Ther. 2007 Mar;37(3):108-14. doi: 10.2519/jospt.2007.2337.

    PMID: 17416125BACKGROUND
  • Strunce JB, Walker MJ, Boyles RE, Young BA. The immediate effects of thoracic spine and rib manipulation on subjects with primary complaints of shoulder pain. J Man Manip Ther. 2009;17(4):230-6. doi: 10.1179/106698109791352102.

    PMID: 20140154BACKGROUND
  • Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

    PMID: 11733293BACKGROUND
  • Schilling DT, Mallace AJ, Elazzazi AM. SHOULDER RANGE OF MOTION CHARACTERISTICS IN DIVISION III COLLEGIATE SOFTBALL AND BASEBALL PLAYERS. Int J Sports Phys Ther. 2019 Sep;14(5):770-784.

    PMID: 31598415BACKGROUND
  • Hammond A, Prior Y, Tyson S. Linguistic validation, validity and reliability of the British English versions of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and QuickDASH in people with rheumatoid arthritis. BMC Musculoskelet Disord. 2018 Apr 16;19(1):118. doi: 10.1186/s12891-018-2032-8.

    PMID: 29661183BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 1, 2020

First Posted

November 6, 2020

Study Start

December 1, 2019

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations