Pain, Shoulder, Shoulder Bursitis, Shoulder Impingement Syndrome, Shoulder Pain, Shoulder Tendinitis
Conditions
Keywords
peripheral nerve stimulation, Sprint, stimulation
Brief summary
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).
Detailed description
The medical and socioeconomic impact of subacute and chronic shoulder pain is high, resulting in 12 million visits to physicians and over $7 billion in direct costs in the United States. The most common cause is subacromial impingement syndrome (SIS), which accounts for 30% of all shoulder pain. Approximately 35% of patients who present with subacromial impingement syndrome (SIS) are refractory to conservative management. For patients who have failed conservative management, there are no established treatments to reduce the pain. The long-term goal is to develop a therapeutic intervention to reduce pain related to subacromial impingement syndrome(SIS). A pilot trial of 3-week percutaneous peripheral nerve stimulation (PNS) for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS) that was refractory to conservative treatment that showed 60% of participants had successful treatment of pain that lasted at least 3 months. Thus, the primary objective of this 2 site randomized control trial (RCT) is to confirm the findings of this preliminary trial and determine the efficacy of peripheral nerve stimulation (PNS) for chronic subacromial impingement syndrome (SIS). The secondary objectives of this multisite randomized control trial (RCT) is to explore mechanisms of peripheral nerve stimulation (PNS) for the treatment of subacromial impingement syndrome (SIS), and to determine which characteristics can predict successful treatment with peripheral nerve stimulation (PNS). In order to accomplish these objectives, this trial is a multi-site, placebo controlled, double-blinded randomized control trial (RCT) to compare the efficacy of peripheral nerve stimulation (PNS) to sham peripheral nerve stimulation (PNS). Measures of pain, pain interference with activities of daily living (ADLs), capacity for activities of daily living (ADLs), Quality of life (QoL), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be measured. Participants will be followed for a total of 24 weeks after treatment has concluded.
Interventions
DEVICEContracting Producing Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.
DEVICENon Contracting Producing Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.
OTHERPhysical Therapy
All participants receive eight 1.0 hr. sessions of physical therapy (PT) over a 4-wk period from a therapist blinded to Peripheral Nerve Stimulation (PNS) treatment assignment. Each participant also performs home exercises. The primary objective of physical therapy (PT) and the home exercise program is to prevent re-injury by educating and training participants in the biomechanics and proper use of the shoulder and upper limb. During each in-lab session, participants are trained in the implementation of these exercises, which are individually adjusted and progressed with increasing external loads by using weights and elastic rubber bands.
Sponsors
University of Texas
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Shoulder pain of \>3 months 2. Age\>=21 3. Worst pain in the last week\>=4 (0-10 scale) 4. Ability to check skin and perform dressing changes, independently or with assistance 5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)
Exclusion criteria
1. Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics 2. Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome) 3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.) 4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks 5. Uncontrolled bleeding disorder 6. Medical instability based on physician opinion after review of medical information 7. Pregnancy 8. Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.) 9. Current Worker's compensation claim for the ipsilateral shoulder 10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination 11. Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by another person)) 12. Current osseus fracture in ipsilateral arm 13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full) 14. Surgical indication for shoulder treatment based on physician opinion 15. Compromised immune system (immunodeficiency or immunosuppression) 16. Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System 17. Patients who have a tape or adhesive allergy 18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in - Short Form (SF) Question 3 (BPI-SF3) | Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment | The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the pain worst rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where 0 indicates No pain and 10 indicates Pain as bad as you can imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a laboratory based objective measure of ADL capacity. The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a timed test that provides a brief measure of functional ability of the upper limb while performing multi-level tasks that require grip/manipulation of the hand, elbow/shoulder reaching, sustained overhead work, and sustained positioning with an emphasis on assessing the limitations in functional capacity attributable to shoulder and neck disorders.The assessor measures the amount of time that the participant is able to perform each task using a stop watch. The task is completed 3 times- waist level, shoulder level, and eye level. Each task is continued for a maximum of 300 seconds or until a stopping criteria is reached. An overall summary score is calculated by averaging the time for the 3 tasks. Higher numbers indicate higher capacity (range 0-300 seconds). |
| Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The questions ask severity of pain based on an 0-10 numerical Rating Scale where 0 = no pain and 10 = the worst pain imaginable. In addition, it asks how much difficulty the participant has on a numerical rating scale where 0 = no difficulty and 10 = so difficult it requires help. Total disability score: \_\_\_\_\_/ 80 x 100 = %. Total SPADI score: \_\_\_\_\_ 130 x 100 = % Higher numbers indicate a higher level of disability (range 0-100%). |
| Change in Quality of Life - Short Form - 12(QoL - SF 12) | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | Quality of life - Short form - 12 (QoL - SF 12) is a health related Quality of life (QoL) measure that assesses physical functioning, role limitation because of physical health problems, bodily pain, social functioning, general mental health, role. Scoring: Two summary scores are a mental component score (MCS-12) and a physical component score (PCS-12). The score ranges from 0 - 100 with higher scores indicating better health. |
Countries
United States
Participant flow
Recruitment details
Recruitment process at MetroHealth and UTSW included the clinics of the investigators and via referral from the PM&R and orthopedic clinics at each institution. Additionally potential participants were recruited from local area via approved recruitment strategies.
Pre-assignment details
no pre assignment conditions were used. Subject who met the inclusion and exclusion criteria for the study were enrolled and randomized to a treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Contraction Producing Peripheral Nerve Stimulation This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy. | 60 |
| Non Contracting Producing Peripheral Nerve Stimulation This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy. | 56 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Contraction Producing Peripheral Nerve Stimulation | Non Contracting Producing Peripheral Nerve Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 47 Participants | 97 Participants |
| Age, Continuous Mean Age | 55.6 years STANDARD_DEVIATION 10.39 | 53.2 years STANDARD_DEVIATION 13.84 | 54.35 years STANDARD_DEVIATION 12.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 50 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 14 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 47 Participants | 38 Participants | 85 Participants |
| Region of Enrollment United States | 60 participants | 56 participants | 116 participants |
| Sex: Female, Male Female | 31 Participants | 27 Participants | 58 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
| Short Form (SF) Question 3 (BPI-SF3) | 6.90 units on a scale STANDARD_DEVIATION 1.76 | 7.05 units on a scale STANDARD_DEVIATION 1.72 | 6.97 units on a scale STANDARD_DEVIATION 1.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 56 |
| other Total, other adverse events | 40 / 60 | 35 / 56 |
| serious Total, serious adverse events | 2 / 60 | 5 / 56 |
Outcome results
Primary
Change in - Short Form (SF) Question 3 (BPI-SF3)
The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the pain worst rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where 0 indicates No pain and 10 indicates Pain as bad as you can imagine.
Time frame: Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment
Population: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contraction Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | Baseline(week 1) | 6.90 units on a scale | Standard Deviation 1.76 |
| Contraction Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | End of treatment (week 9) | 3.58 units on a scale | Standard Deviation 2.59 |
| Contraction Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | 12 week post treatment | 3.51 units on a scale | Standard Deviation 2.9 |
| Contraction Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | 24 weeks post treatment | 3.04 units on a scale | Standard Deviation 2.63 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | 24 weeks post treatment | 3.51 units on a scale | Standard Deviation 2.58 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | Baseline(week 1) | 7.05 units on a scale | Standard Deviation 1.72 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | 12 week post treatment | 3.53 units on a scale | Standard Deviation 2.69 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in - Short Form (SF) Question 3 (BPI-SF3) | End of treatment (week 9) | 3.96 units on a scale | Standard Deviation 2.41 |
Secondary
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a laboratory based objective measure of ADL capacity. The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a timed test that provides a brief measure of functional ability of the upper limb while performing multi-level tasks that require grip/manipulation of the hand, elbow/shoulder reaching, sustained overhead work, and sustained positioning with an emphasis on assessing the limitations in functional capacity attributable to shoulder and neck disorders.The assessor measures the amount of time that the participant is able to perform each task using a stop watch. The task is completed 3 times- waist level, shoulder level, and eye level. Each task is continued for a maximum of 300 seconds or until a stopping criteria is reached. An overall summary score is calculated by averaging the time for the 3 tasks. Higher numbers indicate higher capacity (range 0-300 seconds).
Time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Population: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | Baseline(week 1) | 105.76 Time in seconds | Standard Deviation 82.76 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | End of treatment (week 9) | 146.96 Time in seconds | Standard Deviation 79.27 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | 12 week post treatment | 140.33 Time in seconds | Standard Deviation 86.54 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | 24 weeks post treatment | 154.36 Time in seconds | Standard Deviation 82.88 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | 24 weeks post treatment | 173.61 Time in seconds | Standard Deviation 76.76 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | Baseline(week 1) | 129.95 Time in seconds | Standard Deviation 75.41 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | 12 week post treatment | 175.31 Time in seconds | Standard Deviation 81.13 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | End of treatment (week 9) | 168.32 Time in seconds | Standard Deviation 83.7 |
Secondary
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The questions ask severity of pain based on an 0-10 numerical Rating Scale where 0 = no pain and 10 = the worst pain imaginable. In addition, it asks how much difficulty the participant has on a numerical rating scale where 0 = no difficulty and 10 = so difficult it requires help. Total disability score: \_\_\_\_\_/ 80 x 100 = %. Total SPADI score: \_\_\_\_\_ 130 x 100 = % Higher numbers indicate a higher level of disability (range 0-100%).
Time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Population: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | Baseline(week 1) | 48.97 percentage of total disability | Standard Deviation 22.19 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | End of treatment (week 9) | 25.78 percentage of total disability | Standard Deviation 22.49 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | 12 week post treatment | 23.52 percentage of total disability | Standard Deviation 23.64 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | 24 weeks post treatment | 21.90 percentage of total disability | Standard Deviation 22.03 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | 24 weeks post treatment | 20.75 percentage of total disability | Standard Deviation 21.3 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | Baseline(week 1) | 41.30 percentage of total disability | Standard Deviation 20.57 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | 12 week post treatment | 18.88 percentage of total disability | Standard Deviation 21.73 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) | End of treatment (week 9) | 21.76 percentage of total disability | Standard Deviation 21.07 |
Secondary
Change in Quality of Life - Short Form - 12(QoL - SF 12)
Quality of life - Short form - 12 (QoL - SF 12) is a health related Quality of life (QoL) measure that assesses physical functioning, role limitation because of physical health problems, bodily pain, social functioning, general mental health, role. Scoring: Two summary scores are a mental component score (MCS-12) and a physical component score (PCS-12). The score ranges from 0 - 100 with higher scores indicating better health.
Time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Population: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contraction Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | Baseline (week 1) | 38.43 units on a scale | Standard Deviation 7.9 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | End of Treatment(week 5) | 44.67 units on a scale | Standard Deviation 9.48 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | 12 weeks post treatment | 45.63 units on a scale | Standard Deviation 8.56 |
| Contraction Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | 24 weeks post treatment | 46.97 units on a scale | Standard Deviation 9.32 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | 24 weeks post treatment | 46.94 units on a scale | Standard Deviation 8.99 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | Baseline (week 1) | 39.72 units on a scale | Standard Deviation 8 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | 12 weeks post treatment | 46.39 units on a scale | Standard Deviation 9.54 |
| Non Contracting Producing Peripheral Nerve Stimulation | Change in Quality of Life - Short Form - 12(QoL - SF 12) | End of Treatment(week 5) | 45.85 units on a scale | Standard Deviation 8.56 |