Meniscus Tear
Conditions
Brief summary
Following standard of care procedures for arthroscopy knee surgery it is anticipated that Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and improve functional outcomes.
Interventions
DEVICETENS Treatment with functional or disabled unit
TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
Sponsors
A.T. Still University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 * BMI\<50 * No significant joint malalignment * No significant ligamentous instability * No significant radiographic joint space narrowing * No prior significant knee surgery * Unilateral knee surgery * Not workman's compensation * Planned knee arthroscopy for meniscectomy, chondroplasty or synovectomy
Exclusion criteria
* Age \<18 or \>60 * BMI \> 50 * Significant joint malalignment * Significant ligamentous instability * Significant radiographic joint space narrowing * Prior significant knee surgery * Bilateral knee surgery planned * Worker's Compensation * No planned knee arthroscopy for menisectomy, chondroplasty or synovectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Two weeks postoperatively. | The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Structured TENS Therapy This group will be given an active TENS unit to use.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. | 10 |
| Sham TENS Therapy This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Structured TENS Therapy | Sham TENS Therapy | Total |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 9 | 53.3 years STANDARD_DEVIATION 7 | 50.0 years STANDARD_DEVIATION 8.5 |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain
Time frame: Two weeks postoperatively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 4 | 2.49 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 8 | 3.12 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 1 | 4.68 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 9 | 2.59 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 5 | 3.00 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 10 | 2.85 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 3 | 2.78 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 11 | 2.62 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 6 | 2.20 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 12 | 2.50 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 2 | 3.41 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 13 | 2.42 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 7 | 2.42 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 14 | 2.33 score on 0-10 pain level scale |
| Structured TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 0 | 5.10 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 14 | 3.20 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 0 | 5.24 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 1 | 4.07 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 2 | 3.28 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 3 | 2.95 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 4 | 3.22 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 5 | 3.26 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 6 | 2.72 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 7 | 2.78 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 8 | 2.63 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 9 | 2.35 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 10 | 2.30 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 11 | 2.93 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 12 | 2.66 score on 0-10 pain level scale |
| Sham TENS Therapy | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | Day 13 | 3.02 score on 0-10 pain level scale |