Clinical trial NCT04769128: THORACIC MANIPULATION and COMPLEX REGIONAL PAIN SYNDROME
Official title: INFLUENCE of THORACIC MANIPULATION on TYPE 1 COMPLEX REGIONAL PAIN SYNDROME Post-UPPER LIMB TRAUMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndromes
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: analog scale (VAS)
timeFrame: during 1 day
measure: functional disability using disability of arm, shoulder, and hand questionnaire (DASH).
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Manal M Hassan
Study officials:
affiliation: out pateints clinic, faculty of physical therapy, SVU, Qena. Eygpt. info@pt.svu.edu.eg. 201061792003
name: Manal M Hassan, Msc
role: PRINCIPAL_INVESTIGATOR
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