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Completed

NCT Number: NCT04769128

THORACIC MANIPULATION and COMPLEX REGIONAL PAIN SYNDROME

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manal M Hassan

Aswān, 81511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Thoracic manipulation

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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