THORACIC MANIPULATION and COMPLEX REGIONAL PAIN SYNDROME

February 26, 2021 updated by: Manal Mohammed Hassan, South Valley University

INFLUENCE of THORACIC MANIPULATION on TYPE 1 COMPLEX REGIONAL PAIN SYNDROME Post-UPPER LIMB TRAUMA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Complex regional pain syndrome (CRPS) is a chronic state of pain that is frequently triggered by an injury and is characterized by a variable combination of sensory, motor, vasomotor, and sudomotor symptoms, in the affected limb..the frequency of CRPS after injury was 3.8-7.0 % within four months of fracture. The highest prevalence occurs in the age group of 40 to 60 years. The pathophysiology of CRPS is still controversial, but a recent study has shown that up to 70% of patients with CRPS have anti-autonomic immunoglobulin G (IgG) autoantibodies associated with autonomic disorders in their serum CRPS, increasing the probability of these antiautonomic antibodies contributing to the pathophysiology of CRPS. Under normal conditions, sympathetic behavior does not affect the discharge of nociceptors; but nociceptors tend to be under the control of the sympathetic nervous system (SNS) in the case of CRPS. This is referred to as pain maintained sympathetically. Conservative treatments for CRPS I have traditionally focused on pain reduction through pharmacology, desensitization therapy, transcutaneous electrical stimulation (TENS), and thermal modalities and function restoration through active, passive, and strengthening exercises of the arm.

Patients with arm CRPSI also show postural deviations related to the arm's defensive role. During all upright tasks, this posture reduces trunk motion and can have effects such as reduced thoracic intervertebral mobility. Near to the thoracic costovertebral and zygapophyseal joints are the sympathetic chain ganglia that innervate the upper limb. It may be probable that the sympathetic chain ganglia affected by thoracic dysfunction arising from joint or soft tissue restriction and may be related to the distal symptoms in CRPS. Thus, thoracic spine manipulation can be an aid to the overall treatment of the symptoms in patients with CRPS I. There is no study involving a control group in the available studies. As with all case studies, while the findings might be interesting for future research. our study is the first study to investigate the impact of thoracic manipulation in patients with CRPS1 by comparing between the control group and the experimental group.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Aswan, Egypt, 81511
        • Manal M Hassan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (A) (control group)(traditional physical therapy programme)
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
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.
Other Names:
  • Thoracic manipulation
Experimental: Group (B) (experimental or manipulative 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 in addition to T3-T4 thoracic manipulation (Maitland "screw" technique grade V) 3 sessions/ week for 12 weeks.
Other: Traditional physical therapy programe
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.
Other Names:
  • Thoracic manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analog scale (VAS)
Time Frame: during 1 day
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).
Time Frame: 1 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: Manal M Hassan, Msc, out pateints clinic, faculty of physical therapy, SVU, Qena. Eygpt. info@pt.svu.edu.eg. 201061792003

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2018

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

February 20, 2021

First Submitted That Met QC Criteria

February 20, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thoracic manipulation on CRPS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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