THORACIC MANIPULATION and COMPLEX REGIONAL PAIN SYNDROME

NCT ID: NCT04769128

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-29
• Study Completion Date: 2020-06-20

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.

Conditions

Complex Regional Pain Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Traditional physical therapy programe

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Traditional physical therapy programe

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Thoracic manipulation

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Manal Mohammed Hassan

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manal M Hassan, Msc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Manal M Hassan

Aswān, , Egypt

Countries

Egypt

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Other Identifiers

Thoracic manipulation on CRPS1

Identifier Type: -

Identifier Source: org_study_id