Comparison of the effect of ankle joint mobilization and exercise therapy along with dry needling with ankle joint mobilization and exercise therapy on balance, range of motion, pain and function in patients with chronic ankle instability In Hamedan city: Randomized clinical trial
comparing the effect of ankle joint mobilization and exercise therapy along with dry needling with ankle joint mobilization and exercise therapy on balance, range of motion, pain and function in patients with chronic ankle instability In Hamedan
Design
A randomized blinded control and parallel group clinical trial, Randomization was done with randomizer software.
Settings and conduct
In this study, patients aged 18-50 years with a diagnosis of chronic ankle instability who referred to orthopedic clinics in Hamedan city will be selected and will be divided into two intervention and control groups by simple randomization method. The intervention group will receive the combination of ankle joint mobilization and exercise therapy along with dry needling, and in the control group, ankle joint mobilization and exercise therapy will be applied. This study will be done by blinding the evaluator. The person who does the assessment is different from the person who does the treatment. Also, data analysis is done by another person who is unaware of the evaluation and treatment.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 50 with chronic one-sided ankle instability referring to physical medicine and orthopedic clinics of Hamedan University of Medical Sciences were included in the study, among them, patients who had a history of surgery or fracture in any of the lower limbs were excluded from the study. .
Intervention groups
The intervention group receives ankle mobilization and exercise therapy along with dry needling, while the control group receives ankle mobilization and exercise therapy.
Main outcome variables
Dynamic balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230205057336N3
Registration date:2024-01-07, 1402/10/17
Registration timing:prospective
Last update:2024-01-07, 1402/10/17
Update count:0
Registration date
2024-01-07, 1402/10/17
Registrant information
Name
Narges Meftahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1552
Email address
meftahin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ankle joint mobilization and exercise therapy along with dry needling with ankle joint mobilization and exercise therapy on balance, range of motion, pain and function in patients with chronic ankle instability In Hamedan city: Randomized clinical trial
Public title
Comparison of the effect of ankle joint mobilization and exercise therapy along with dry needling with ankle joint mobilization and exercise therapy on balance, range of motion, pain and function in patients with chronic ankle instability In Hamedan city: Randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with unilateral chronic ankle instability aged between 18-50 years
A history of at least one ankle sprain in the past 12 months with symptoms of inflammation that prevented activity for at least one day
At least three months have passed since the last ankle sprain.
People who have a feeling of instability or recurrent ankle sprains (two or more cases in one ankle) or ankle sprains (at least two cases in six months).
Trigger points in at least one of the muscles: Peroneus Longus, peroneus brevis, gastrocnemius and anterior tibialis
ankle instability scores 25 and less in Cumberland ankle instability tool
Foot and Ankle Ability Measurement questionnaire (FAAM) (Home scale<90%, sport scale<80%)
Exclusion criteria:
History of any musculoskeletal surgery in any of the lower limbs
History of fractures in any of the lower limbs
Having diseases related to imbalance (people with peripheral neuropathy, MS, Parkinson's, migraine, radiculopathy and diseases related to the middle ear)
Individuals who received physical therapy and dry needling for pain from their CAI in the past 6 months
history of skeletal-muscular injuries in other joints of the lower limbs in the last three months
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using the randomizer software, 40 numbers are considered for each case and the software creates 10 blocks of 4 using permutation randomization, of which 2 people enter the first group and 2 people enter the second group. and it will be done in this way until number 40.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person who performs the evaluation is different from the person who performs the treatments. Also, data analysis is done by another person who is unaware of the evaluation and treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in shiraz faculty of rehabilitation sciences research
Before, immediately after and four weeks after the end of the intervention
Method of measurement
Modified star excursion balance test
2
Description
Ankle dorsiflexion range of motion
Timepoint
Before, immediately after and four weeks after the end of the intervention
Method of measurement
weight bearing lung test
3
Description
Pain
Timepoint
Before, immediately after and four weeks after the end of the intervention
Method of measurement
Visual analogue scale
4
Description
Function
Timepoint
Before, immediately after and four weeks after the end of the intervention
Method of measurement
Foot and Ability Measure questionnaire
Secondary outcomes
1
Description
severity of functional ankle instability
Timepoint
Before, immediately after and four weeks after the end of the intervention
Method of measurement
Cumberland Ankle Instability Tool (CAIT)
Intervention groups
1
Description
Intervention group: Ankle mobilization group and dry needling exercise therapy: patients in this group, in addition to ankle mobilization treatment exactly the same as the first group, dry needling for four sessions and once a week, for at least one of the peroneus longus, peroneus muscles Brevis, gastrocnemius and tibialis anterior will receive.
Category
Treatment - Other
2
Description
Control group: Ankle mobilization group and therapeutic exercise: joint mobilization will be done when the patient is lying in an open arch and the ankle is out of the edge of the bed. Then the ankle is placed in 20 degrees of plantar flexion so that the talocrural joint is in a loose-packed position. The stabilizer hand is placed above the ankles (to stabilize the leg), while the mobilizer hand grabs the talus with the first web, then the talus is given a 4-grade glide with downward force. Mobilization for the relevant groups will be held for three sessions.