The effects of conventional physical therapy with and without neck manual therapy on clinical outcomes in people with carpal tunnel syndrome
Design
Randomized control trial with 2 group of control and treatment design of 40 patients, double-blind, with a parallel group.
Settings and conduct
Patients are randomly assigned to either intervention or treatment groups at Golestan hospital in Ahvaz. In this study, patients and assessors are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Tingling, numbness, burning or pain in at least 2 of digits 1, 2 or 3.
Ages range between 18 to 60.
Positive result Phalen or Tinnel sign or Carpal compression test.
Existance CTS symptoms for greater than twelve weeks.
Pain intensity at least a 4/10 on a Visual Analog Scale over the past 24 h.
Electrodiagnostic findings indicate mild to moderate damage to the median nerve.
Exclusion criteria:
Any sensory or motor deficit in either the ulnar or radial nerve.
History of surgery or injection in the wrist area.
Presence of systemic diseases such as rheumatoid arthritis, fibromyalgia, diabetes mellitus , hyperthyroidism or hypothyroidism
The presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy.
Pregnancy.
History of neck, shoulder or upper extremity trauma.
Intervention groups
Intervention group: Combined conventional physiotherapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy and neck manual therapies.
Control group: Conventional physiotherapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy
Main outcome variables
Pain, upper limb level of function, symptoms and functional status of patients, median sensory nerve conduction velocity, median nerve motor distal latency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201201049565N1
Registration date:2020-12-15, 1399/09/25
Registration timing:registered_while_recruiting
Last update:2020-12-15, 1399/09/25
Update count:2
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Milad Zarrin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3524 7102
Email address
miladzarrin.pt1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-01, 1399/09/11
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of conventional physical therapy with and without neck manual therapy on clinical outcomes in people with carpal tunnel syndrome
Public title
The effects of neck manual therapy on the carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tingling, numbness, burning or pain in at least 2 of digits 1, 2 or 3
Ages 18-60 years
Positive Phalen sign or Tinnel sign over the carpal tunnel or carpal compression test
CTS symptoms present for greater than twelve weeks
Pain intensity at least a 4/10 on a Visual Analog Scale scale over the past 24 h
Electrodiagnostic findings indicate mild to moderate damage to the median nerve
Exclusion criteria:
Any sensory or motor deficit in either the ulnar or radial nerve
History of surgery or injection in the wrist area
Presence of systemic diseases such as rheumatoid arthritis, fibromyalgia
A history of systemic disease associated with carpal tunnel syndrome (such as diabetes mellitus or hyperthyroidism or hypothyroidism)
The presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy
Pregnancy
History of neck, shoulder or upper extremity trauma
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who met the inclusion criteria were randomly
allocated to Group A (conventional physiotherapy) or Group B (combination of conventional physiotherapy treatments with neck manual therapy) using Block randomization (size: 4 and 6) prepare by an independent statistician with no clinical involvement in the trial. The allocation will be concealed in opaque, sealed envelope. A research assistant opens the envelopes to reveal group allocation before starting the intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind clinical trial in which patients are evaluated by another physiotherapist who is unaware of assigning individuals to groups. Patients and data analysts will also be unaware of group assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences