THORACIC MANIPULATION and COMPLEX REGIONAL PAIN SYNDROME

NCT04769128 | Completed

• 1 other identifier: Thoracic manipulation on CRPS1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of combined thoracic manipulation (TM) and traditional physical therapy treatment (TPT) versus TPT treatment alone on pain severity at rest and functional disability in patients with type 1 complex regional pain syndrome (CRPS I) post-upper limb trauma.

Conditions

Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (2)

• analog scale (VAS)

  The patient is asked to draw a line at the point that represents their pain severity perpendicular to the VAS line. The score is measured by calculating the distance (mm) on the 10-cm line between the 'no pain' anchor and the mark of the patient by using a ruler, including a selection of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). A difference of more than 12 mm is considered the minimum clinically important difference. The patient rated the pain severity at rest.

  during 1 day

• functional disability using disability of arm, shoulder, and hand questionnaire (DASH).

  DASH is a self-assessment of symptoms and function of the entire upper extremity. Self-assessment and scoring by calculating the arithmetic mean of at least 27 of the 30 items (missing rule) is transformed by (mean - 1) x 25 into the scale from 0 no symptoms/full function to 100 maximal symptoms/no function for the DASH total score. Five of 6 items are necessary for determination of the symptoms score and 22 of 24 items for the function score. Originally, 0 best and 100 worst. All items are easy to comprehend and are not emotionally sensitive (with the exception of item 21). All items are scored on a scale of 5 (Likert) levels: (1) no difficulty/ symptoms, (2) mild difficulty/ symptoms, (3) moderate difficulty/symptoms, (4) severe difficulty/ symptoms, and (5) extreme difficulty (unable to do)/symptoms. Minimal Clinical Important Difference (MCID): 10.2 points. In our current study, the Arabic version was used

  1 week

Study Arms (2)

Group (A) (control group)(traditional physical therapy programme)

ACTIVE COMPARATOR

Group (A) (control group): Fifteen patients with CRPS I received traditional physical therapy program in the form of transcutaneous electrical neuromuscular stimulation (TENS), mirror therapy, and exercises for upper limb exercises in the form of gradual weight-bearing exercises by using different equipment such as balls, balloons, or silk-like cloths, combined with different positions of the patient (i.e. lying, sitting, or standing), range of motion exercises (active and self-Assisted), resisting exercises (manual and mechanical), stretching exercises (manual and self-stretching) and fine motor control training. 3 sessions/ week for 12 weeks.

Other: Traditional physical therapy programe

Group (B) (experimental or manipulative group)

EXPERIMENTAL

Fifteen patients with CRPS I received traditional physical therapy program in the form of transcutaneous electrical neuromuscular stimulation (TENS), mirror therapy, and exercises for upper limb exercises in the form of gradual weight-bearing exercises by using different equipment such as balls, balloons, or silk-like cloths, combined with different positions of the patient (i.e. lying, sitting, or standing), range of motion exercises (active and self-Assisted), resisting exercises (manual and mechanical), stretching exercises (manual and self-stretching) and fine motor control training in addition to T3-T4 thoracic manipulation (Maitland "screw" technique grade V) 3 sessions/ week for 12 weeks.

Other: Traditional physical therapy programe

Interventions

Traditional physical therapy programe OTHER

thoracic manipulation spine at the level of T3 and T4 facet joints (Maitland (screw) technique grade V). Using hypothenar eminence of hands, applying direct downward pressure and additional force-directed caudal with one hand and cephalic with the other hand on the transverse processes.

Also known as: Thoracic manipulation

Group (A) (control group)(traditional physical therapy programme); Group (B) (experimental or manipulative group)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Thirty patients were diagnosed according to International Association for the Study of Pain (IASP) criteria with CRPS I (10 to 18 weeks duration of illness) from both genders and referred from orthopedists post fractures in different upper limb regions (such as shoulder region e.g. clavicle and proximal humerus, elbow region e.g. distal humerus, proximal radius and ulna, and wrist region e.g. distal radius, ulna, and carpal bones), their age was between 40 and 60 years.

You may not qualify if:

• Patients who had a stroke, any history of autoimmune or peripheral vascular diseases, diabetes, T4 syndrome, as well as patients, received physical therapy program before

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Manal M Hassan

Aswān, 81511, Egypt

Location

Related Publications (13)

• Marinus J, Moseley GL, Birklein F, Baron R, Maihofner C, Kingery WS, van Hilten JJ. Clinical features and pathophysiology of complex regional pain syndrome. Lancet Neurol. 2011 Jul;10(7):637-48. doi: 10.1016/S1474-4422(11)70106-5.

  PMID: 21683929 RESULT

• Beerthuizen A, Stronks DL, Van't Spijker A, Yaksh A, Hanraets BM, Klein J, Huygen FJPM. Demographic and medical parameters in the development of complex regional pain syndrome type 1 (CRPS1): prospective study on 596 patients with a fracture. Pain. 2012 Jun;153(6):1187-1192. doi: 10.1016/j.pain.2012.01.026. Epub 2012 Mar 3.

  PMID: 22386473 RESULT

• Bruehl S, Maihofner C, Stanton-Hicks M, Perez RS, Vatine JJ, Brunner F, Birklein F, Schlereth T, Mackey S, Mailis-Gagnon A, Livshitz A, Harden RN. Complex regional pain syndrome: evidence for warm and cold subtypes in a large prospective clinical sample. Pain. 2016 Aug;157(8):1674-81. doi: 10.1097/j.pain.0000000000000569.

  PMID: 27023422 RESULT

• Kohr D, Singh P, Tschernatsch M, Kaps M, Pouokam E, Diener M, Kummer W, Birklein F, Vincent A, Goebel A, Wallukat G, Blaes F. Autoimmunity against the beta2 adrenergic receptor and muscarinic-2 receptor in complex regional pain syndrome. Pain. 2011 Dec;152(12):2690-2700. doi: 10.1016/j.pain.2011.06.012. Epub 2011 Aug 3.

  PMID: 21816540 RESULT

• Dubuis E, Thompson V, Leite MI, Blaes F, Maihofner C, Greensmith D, Vincent A, Shenker N, Kuttikat A, Leuwer M, Goebel A. Longstanding complex regional pain syndrome is associated with activating autoantibodies against alpha-1a adrenoceptors. Pain. 2014 Nov;155(11):2408-17. doi: 10.1016/j.pain.2014.09.022. Epub 2014 Sep 22.

  PMID: 25250722 RESULT

• Sillevis R, Cleland J, Hellman M, Beekhuizen K. Immediate effects of a thoracic spine thrust manipulation on the autonomic nervous system: a randomized clinical trial. J Man Manip Ther. 2010 Dec;18(4):181-90. doi: 10.1179/106698110X12804993427126.

  PMID: 22131791 RESULT

• Benarroch EE. Pain-autonomic interactions. Neurol Sci. 2006 May;27 Suppl 2:S130-3. doi: 10.1007/s10072-006-0587-x.

  PMID: 16688616 RESULT

• Vernon HT, Triano JJ, Ross JK, Tran SK, Soave DM, Dinulos MD. Validation of a novel sham cervical manipulation procedure. Spine J. 2012 Nov;12(11):1021-8. doi: 10.1016/j.spinee.2012.10.009. Epub 2012 Nov 15.

  PMID: 23158966 RESULT

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 RESULT

• 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: 11733293 RESULT

• Angst F, Goldhahn J, Drerup S, Flury M, Schwyzer HK, Simmen BR. How sharp is the short QuickDASH? A refined content and validity analysis of the short form of the disabilities of the shoulder, arm and hand questionnaire in the strata of symptoms and function and specific joint conditions. Qual Life Res. 2009 Oct;18(8):1043-51. doi: 10.1007/s11136-009-9529-4. Epub 2009 Aug 26.

  PMID: 19707887 RESULT

• Packham T, Holly J. Complex regional pain syndrome: Measurement matters: Re: Galve-Villa M, Rittig-Rasmussen B, Mikkelsen LMS, Poulsen AG. Complex Regional Pain Syndrome. Manual Therapy 2016;26:e2-3. Man Ther. 2016 Dec;26:e1. doi: 10.1016/j.math.2016.07.012. Epub 2016 Aug 2. No abstract available.

  PMID: 27527554 RESULT

• Harden RN, Oaklander AL, Burton AW, Perez RS, Richardson K, Swan M, Barthel J, Costa B, Graciosa JR, Bruehl S; Reflex Sympathetic Dystrophy Syndrome Association. Complex regional pain syndrome: practical diagnostic and treatment guidelines, 4th edition. Pain Med. 2013 Feb;14(2):180-229. doi: 10.1111/pme.12033. Epub 2013 Jan 17.

  PMID: 23331950 RESULT

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Manal M Hassan, Msc

  out pateints clinic, faculty of physical therapy, SVU, Qena. Eygpt. info@pt.svu.edu.eg. 201061792003

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 24, 2021
• Study Start: July 29, 2018
• Primary Completion: April 1, 2020
• Study Completion: June 20, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)