Effects of Echoguided Percutaneous Neuromodulation (EPNM) of the Common Peroneal Nerve and Neuromuscular Exercise in the Management of Chronic Ankle Instability (CAI): a Randomized Clinical Trial (RCT).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- "Numeric Pain Rating Scale" (NPRS)
Study Overview
Brief Summary
The lateral ankle complex sprain is the most prevalent musculoskeletal injury among the general population and athletes and is associated with long-term pain, disability, and high healthcare costs. One of the complications of a lateral ankle sprain is the development of chronic ankle instability (CAI). Conservative treatment is the initial therapeutic option for patients with CAI, however, the best strategies are not yet clear. Clinically, a new invasive technique has appeared, known as echoguided Percutaneous Neuromodulation (EPNM). To date there are no studies showing the efficacy of the technique in patients with CAI together with the combination of a neuromuscular exercise program.
Participants: Volunteers and adults, from the group of students of the Gimbernat University School with a history of ankle sprain and physically active who meet the inclusion criteria.
Study variables: Self-administered ankle function scales (Cumberland ankle instability tool: CAIT and foot and ankle ability:FAAM measure Scale), objective measurement of function in the lower limb (Test countermovement jump: CMJ and Side hop Test:SHT), measurement of isometric strength of the ankle musculature, measurement of dynamic balance (Test star excursion balance), range of motion measurement (Ankle Dorsiflexion) and pain measurement (Numeric pain rating scale: NPRS Scale).
Procedures: After carrying out the assessment, the participants will be randomized to participate in a neuromuscular exercise intervention (control group) or in a neuromuscular exercise intervention together with an application of EPNM in the common peroneal nerve (control group). experimental). The duration of the intervention in both cases will be 3 weeks, where in the control group there will be 2 sessions per week of exercise and in the experimental group 2 sessions per week of exercise plus an application of EPNM.
Objective and hypothesis: The main objective of the study will be to compare the short- and medium-term effects of both interventions in relation to the study variables to be measured. The investigators hypothesize that those patients who receive neuromodulation combined with the neuromuscular exercise program will have greater improvements.
Detailed Description
The lateral ankle complex sprain is the most prevalent musculoskeletal injury among the general population and athletes and is associated with long-term pain, disability, and high health costs. A review of ankle injuries on 70 analyzed sports established that lateral ankle sprains accounted for 77% of all injuries, where the highest incidence rates were found in sports characterized by running, changes of direction or running. jump like basketball, soccer or volleyball.One of the complications of lateral ankle sprain is the development of chronic ankle instability (CAI) characterized by repeated episodes or perceptions of ankle instability, persistent symptoms such as pain, swelling, and decreased function with limitations in activities of daily living and sports participation that persist more than a year after the initial injury. Conservative treatment is the initial therapeutic option for patients with CAI, however, the best strategies are not yet clear. Numerous rehabilitation protocols to improve CAI-associated deficits have been examined. These range from simple progressive strength work or postural dynamic balance protocols to multi-component (strength, balance, mobility) rehabilitation approaches with effective results in improving strength. , balance and in function.Clinically, a new invasive technique has appeared, known as echoguided Percutaneous Neuromodulation (EPNM). This minimally invasive intervention consists of the application of percutaneous electrical stimulation (biphasic square wave electrical current) through an acupuncture needle, as an electrode located in the vicinity of the nerve or motor point of the muscle to be treated under the guidance ultrasound where the generation of structural and excitation changes in the nerve is hypothesized, which as a consequence produces a decrease in its sensitization. It is an accessible, safe and economical technique to treat musculoskeletal conditions by physiotherapists. To date, there is limited evidence regarding its use. EPNM has been applied to different pathologies with good therapeutic results, but its use together with the combination of a multicomponent neuromuscular exercise program has never been studied.The main objective of the study will be to compare the effects in the short and medium term of an intervention with EPNM in the common peroneal nerve together with an exercise program in relation to the variables pain, range of motion in the ankle, strength of the ankle musculature , dynamic balance and functionality both in performance and in self-reports in patients with CAI.
Participants:
Voluntary subjects and adults, from the group of students of the Gimbernat University School with a history of ankle sprain and physically active, defined as participation in moderate aerobic physical activity of at least 30 minutes 5 days a week, or vigorous aerobic intensity of at least 20 minutes 3 days a week, will be evaluated to see if they can participate and be included in the study.
Variables under study:
Principal:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
The statistical analysis investigator will be masked.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of at least one major ankle sprain. The initial sprain must have occurred at least 12 months prior to study participation, be associated with inflammatory symptoms (pain, edema) and have generated at least one day of interruption in physical activity.
- •The most recent sprain must have occurred at least 3 months prior to study participation.
- •History in the injured ankle of "dropping the ankle" (at least 2 episodes in the 6 months prior to study participation) and/or repeated sprains (two or more sprains in the same ankle) and/or feelings of instability in activities of daily living or sports (score less than 24 on the Cumberland Ankle Instability Tool (CAIT).
- •Have a score of less than 75% in three or more categories in the Foot and ankle Outcome Score(FAOS) or a level of less than 80% in sports activities in the Foot and ankle ability measure (FAAM).
- •Pain on the Numeric pain rating scale (NPRS) above 3 points out of 10 in their physical activity.
Exclusion Criteria
- •History of surgery in either of the two lower extremities that may interfere with the performance of the tests.
- •History of a fracture in either of the two lower extremities requiring alignment.
- •Acute injury to the musculoskeletal structures of other lower extremity joints in the previous 3 months, which impact joint integrity and function, resulting in at least one day of loss of physical activity.
- •Chronic concomitant pathology at the level of the lower extremity (for example: osteoarthritis, vascular disease, neural pathology).
- •Regular use of analgesic medication that may mask symptoms.
- •Contraindications of percutaneous puncture and specific to the execution of neuromodulation.
- •Being receiving physiotherapy or medical treatment during the intervention.
- •Being pregnant at the start of the study.
Outcomes
Primary Outcomes
"Numeric Pain Rating Scale" (NPRS)
Time Frame: Through study completion, an average of 1 year
Scale used to assess pain intensity, where 0 is absence of pain and 10 represents maximum pain.There are no data for the MCID in patients with CAI, however it appears that changes between 1.5 and 2.1 points can be considered as the MCID for patients with musculoskeletal pain conditions. This variable will ask about the intensity of pain during sports practice.
"Foot and ankle ability measure" : FAAM questionnaire
Time Frame: Through study completion, an average of 1 year
It is a Likert scale that consists of 29 items, which have a score from 0 to 4, representing different levels of difficulty, divided into two subscales: activities of daily living (ADL) (21 items) and sports (8 items). items). The values are added to calculate the result of each subscale, 84 points for ADLs and 32 points for sports. For the analysis of the result, the percentage of each subscale is used separately. The test-retest reliability is high, 0.89 for the ADLs and 0.87 for the sports subscale. In fact, the FAAM scale has been shown to be valid for use in patients with ankle instability. It has been suggested that the minimal clinically important difference (MCID) is 8 and 9 points for the ADL subscale and the sports subscale, respectively.
"Cumberland Ankle Instability Tool" (CAIT)
Time Frame: Though study completion, an average of 1 year
It has shown to be a valid and reliable tool to assess functional ankle instability. With an intraclass correlation coefficient (ICC) of 0.96, the CAIT scale has demonstrated excellent test-retest reliability. The scale consists of 9 items with a maximum score of 30 points, where the highest results indicate greater stability. It has been suggested that the MCID is 3 or more points.
Secondary Outcomes
- "Star Excursion Balance Test" (SEBT)(Though study completion, an average of 1 year)
- Range of Motion (ROM)(Though study completion, an average of 1 year)
- "Side hop test" (SHT)(Though study completion, an average of 1 year)
- Isometric ankle strength measurement(Though study completion, an average of 1 year)
- "Countermovement jump unilateral test" (Unilateral CMJ)(Though study completion, an average of 1 year)