NCT02893267

Multimodal Treatment for Hemiplegic Shoulder Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke survivors. HSP is associated with poor rehabilitation outcomes, including interference with activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for HSP have been proposed, most do not result in long-term relief of pain. The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only treatment to provide long-term relief of pain for those with HSP. However, physical therapy (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical community, the superiority of PNS to a course of PT must be demonstrated. The investigators completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants experienced successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively. Thus, the primary objective of this 2-site RCT is to confirm the findings of this preliminary pilot RCT. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice, may have a synergistic therapeutic effect. Thus, the second objective of this RCT is to determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief than PNS alone or PT alone. Mechanisms also will be explored.

Detailed description

Study Summary: This is a multi-site, placebo controlled, double-blinded RCT to confirm the superiority of PNS over PT in reducing HSP, and to determine if multimodal treatment of HSP with PNS + PT is more efficacious than PNS or PT alone. The standard of care for treating shoulder pain is to try several options, most commonly including medications, injections and therapy. Candidates considering this study likely have tried some treatments but without lasting success. Ninety-six participants will be randomized to receive PNS + PT, PNS + sham-PT, or sham-PNS + PT. The PNS + PT group will receive active PNS therapy for 6 hours per day for 3 weeks along with 8 sessions of PT to improve biomechanics of the affected shoulder. The PNS+ sham-PT group will receive active PNS therapy and sham-PT, consisting of placebo ultrasound, application of inert gel, lower limb strengthening, and walking exercises. The sham-PNS + PT group will receive a percutaneous lead in a similar manner as the active therapy groups, but with sham-stimulation, along with 8 sessions of PT. Measures of pain, pain interference with ADLs, QoL, shoulder biomechanics (shoulder abduction torque, shoulder kinematics, and Fugl-Meyer score), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be assessed at baseline and at weeks 4 (end of treatment), 8, 12, 16, 20, 24, and 28.

Conditions

• Stroke
• Shoulder Pain

Interventions

Type	Name	Description
DEVICE	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 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. Total time of electrode implantation is no more than 29 days.
OTHER	Physical Therapy	Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
OTHER	Sham-PT	Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist and study staff in a therapeutic environment. Participants will undergo a hands-on evaluation and re-evaluation before and after treatment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
DEVICE	Sham-PNS	The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.

Timeline

• Start date: 2017-01-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2016-09-08
• Last updated: 2025-12-22
• Results posted: 2025-12-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study