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Frozen ShoulderNCT04619173

Additional Effects of Thoracic Manipulation in Adhesive Capsulitis.

A study testing Thoracic manipulation and Conventional physical therapy Program in people with Frozen Shoulder, run by Riphah International University at 1 site in Pakistan.

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

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. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Frozen Shoulder
What is being tested?
Thoracic manipulation and Conventional physical therapy Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
1 Dec 2019to 20 Dec 2020
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Helping Hand Institute of Rehabilitation Sciences

    Mānsehra, KPK, 21300

Other trials in Pakistan

About this study

Official title: Additional Effects of Thoracic Manipulation in Patients With Adhesive Capsulitis.

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.

Read the detailed description

Frozen shoulder is a widespread disabling condition which causes significant disability. In spite of hundred years of treating this condition the clarity, diagnosis, pathology and most effectual treatments are still need to be explored.It is characterized by the impulsive onset of pain, inflexibility and restricted range of motion at the shoulder joint. The pathophysiology of frozen shoulder is not exactly known. However it is generally supposed that a combination of contracture of capsule, rotator cuff tendon fibrosis, sub-scapular depression and the coraco-humeral ligament lead to comprehensive movement restriction at the glenohumeral joint. Frozen shoulder is considered to have an occurrence of 3%-5% in the common population and up to 20% in those with diabetes mellitus. Between the ages of 40 and 60 it is most prevalent and is almost not found in ages below that and in persons who work manually. It is somewhat more common in women then man. Bilateral frozen shoulder occurs in 14% of population and up to 20% of population will develop some degree of related symptoms in the other shoulder. the most common associated risk factor for developing the frozen shoulder is diabetes mellitus, and a patient with diabetes has 10%-20% risk of developing frozen shoulder.

Thoracic spine manipulation has received growing attention in treating the patients with shoulder pain. Recent studies have shown that thoracic manipulation is an effective combination therapy for patients with shoulder pain. The position of thoracic spine significantly have an effect on shoulder joint and shoulder kinematics during movement on different planes as there is decreased muscle force when a person is in a slouch position. Thoracic Spine manipulation is a treatment choice by the number of health professionals especially the physical therapist. Literature defines thoracic manipulation as highly practiced and skilled passive thrust to joints and adjacent structures and soft tissues at variable intensity consisting of small amplitude and high velocity therapeutic movements at thoracic spine including cervicothoracic junction. Much of the recent studies are focusing on the relationship of thoracic spine to other body regions such as neck and shoulder rather than thoracic spine itself this phenomenon is described as regional interdependence.although cervical spine manipulation has also improve pain and disability in patients with non-specific shoulder pain but have some evidence of thrust complications relating to cervical spine. Similar neurophysiologic associations are documented with thoracic spine manipulation in relation with shoulder pain with less complications and thrust risk.

Spinal manipulation of the thoracic spine can be an effective intervention for treating patients with shoulder pain or dysfunctions. Treatment protocols focusing the thoracic spine must be added to the intervention of rehabilitation of patients with shoulder pain in clinical practice. In common clinical practice a series of thoracic hypomobility has been noticed at the T1-T3 spinal segments or the T3-T5 segments in patients with shoulder pathologies. In literature manipulation of thoracic regions has been shown to produce improvement in upper extremity blood flow and circulation. Researches related to thoracic spine manipulation is signifying a association between manipulation of the thoracic spine and enhancement in shoulder function and potency. Thus the purpose of the study is to evaluate the possible effect of thoracic manipulation on shoulder range of motion and function in combination with conventional intervention for the individuals with frozen shoulder.

Thoracic spine thrust manipulation provided a statistically significant decrease in self-reported pain measures and disability in patients with Shoulder impingement syndrome. Thoracic spine and upper rib manipulative therapy is associated with improvement in shoulder pain and ROM immediately following intervention in patients with a primary complaint of shoulder pain. Thoracic spine manual therapy accelerated recovery and reduced pain and disability in patients having nonspecific shoulder pain (NSSP). Thoracic and rib manipulation is effective in relieving pain and improving range of motions and reducing disability in frozen shoulder patients. Cervical thoracic junction and upper thoracic spine manipulations in combination with traditional physical therapy will decrease pain, increase range of motion, and increase function in patients suffering from internal impingement syndrome more than patients who received traditional physical therapy treatment and posterior and inferior mobilization.

Conditions
Frozen Shoulder
Being tested
Thoracic manipulation, Conventional physical therapy Program
Keywords
Frozen Shoulder, Thoracic Manipulation
Medical subject headings
Bursitis

What participants receive

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

  • Thoracic manipulationOther

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

  • Conventional physical therapy ProgramOther

    hot pack ,transcutaneous electrical nerve stimulation and stretching

Study groups in NCT04619173
Study groupRoleWhat they receive
Thoracic manipulationExperimentaladditional thoracic manipulation along with hotpack, transcutaneous electrical nerve stimulation ,serratus anterior,pectoralis major,minor, posterior capsular stretches..
Receives: Other: Thoracic manipulation
Conventional Physical Therapy ProgramActive comparatorhot pack transcutaneous electrical nerve stimulation, serratus,anterior,pectoralis major, minor, posterior capsular stretches.
Receives: Other: Conventional physical therapy Program

What is being measured

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

  1. 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

    Measured: 3 weeks

  2. Bubble Inclinometer

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

    Measured: 3 weeks

  3. (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.

    Measured: 3 weeks

Timeline

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

  1. First posted6 Nov 2020
  2. Study start1 Dec 2019
  3. Primary completion20 Dec 2020
  4. Study completion20 Dec 2020

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619173
Sponsor's protocol ID
REC/00675 Ubaidullah Bilal
Status last verified
Dec 2024
First submitted
1 Nov 2020
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25793166
  • 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.

    PubMed 25543999
  • 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.

    PubMed 10453773
  • 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.

    PubMed 20140155
  • 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.

    PubMed 26917935
  • 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.

    PubMed 18703377
  • 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.

    PubMed 26957759
  • 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.

    PubMed 29020962
  • 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.

    PubMed 26476720
  • 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.

    PubMed 28874727
  • 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.

    PubMed 30762780
  • 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.

    PubMed 17416125
  • 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.

    PubMed 20140154
  • 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.

    PubMed 11733293
  • 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.

    PubMed 31598415

Questions about this trial

What is this clinical trial studying?

A study testing Thoracic manipulation and Conventional physical therapy Program in people with Frozen Shoulder, 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 3 inclusion and 8 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 17 Dec 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 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?

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?

Visual analogue scale (VAS): (time frame: 3 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 NCT04619173, which also lists 16 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 17 Dec 2024.

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