Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation

• ClinicalTrials.gov Identifier: NCT03170557
• Recruitment Status: Recruiting
• First Posted: May 31, 2017
• Last Update Posted: September 9, 2020
• Sponsor: Montecatone Rehabilitation Institute S.p.A.
• Collaborator: Associazione Medici Agopuntori Bolognesi (A.M.A.B.)
• Information provided by (Responsible Party): Montecatone Rehabilitation Institute S.p.A.

Tracking Information

• First Submitted Date: May 26, 2017
• First Posted Date: May 31, 2017
• Last Update Posted Date: September 9, 2020
• Actual Study Start Date: September 25, 2017
• Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 30, 2017)

Pain reduction [ Time Frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12) ]

Pain reduction of at least 2 points on the NRS scale

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 30, 2017)

• Persistence of pain reduction in Acupuncture arm [ Time Frame: Follow-up 2 (9 weeks after closing session 12) ]
  Pain reduction of at least 2 points on the NRS scale
• Reduction of drugs intake [ Time Frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12) ]
  Intake reduction of antalgic, hypnotic and anxiolytic drugs (number and dosage)
• Reduction of Anxiety/Depression [ Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12) ]
  Reduction of anxiety/depression symptoms, assessed by Hospital Anxiety and Depression Scale
• Reduction of pain interference on sleep and quality of life [ Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12) ]
  Reduction of pain interference on sleep and quality of life, assessed by Multidimensional Pain Inventory scale, Part 1
• Improvement of quality of life [ Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12) ]
  Increase of participation in family and social life, assessed by Multidimensional Pain Inventory scale, Part 2

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 30, 2017)

• Patient satisfaction [ Time Frame: Closing session 12 (6 weeks) ]
  Assessment of patient satisfaction after antalgic treatment by an in-house developed ad-hoc questionnaire
• Adverse events [ Time Frame: Session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12) ]
  Recording possible adverse events attributable to the experimental treatments

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
• Official Title: A Randomized, Double Blind, Comparative Trial to Assess the Efficacy of Traditional Acupuncture vs Aspecific Needle Skin Stimulation for Persistent Pain in Subjects With Spinal Cord Injury
• Brief Summary: Pain is one of the most common problems in patients with spinal cord injury (SCI) and persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often poorly responsive to pharmacological therapy. Attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain in other clinical conditions, and acupuncture has been the treatment most used and appreciated for its effectiveness. However, only few studies are available on the use of acupuncture in SCI patients. The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies.

Detailed Description

About 67% of patients with spinal cord injury (SCI) experience painful symptoms in the course of life after injury and a third evaluates the pain as "severe", with a significant impact on quality of life, due to limitations in daily activities and autonomy. Persistent pain can be of different origin and may be nociceptive, neuropathic or mixed. However, it is often poorly responsive to pharmacological therapy. For some years, attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain, and acupuncture has been the treatment most used and appreciated for its effectiveness. Only two studies on the use of acupuncture in SCI patients were included in the only Cochrane review available, dated 2014. Such studies, focusing on the painful shoulder syndrome and, therefore, on skeletal muscle pain, show a "non-superiority" of acupuncture compared to sham acupuncture treatment or Trager approach. However, the review does not come to any clear conclusions on the effectiveness of intervention because of the small number of cases and high risk of bias.

A more recent primary, randomized, controlled trial on SCI patients, although focusing on chronic pain and on a single acupuncture technique, uses a questionable study design (cross-over) to demonstrate treatment efficacy.

The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies. Because of the intrinsic effects of sham acupuncture and, generally, of skin stimulation, a statistically significant change in the Numerical Rating Scale (NRS) measurements is expected even in the comparison group. To minimize this bias, which cannot be avoided, and to maintain the blindness of the patient as much as possible, the comparison group is treated by the insertion of needles in skin areas outside the metamer(s) affected by pain.

Primary objective:

- To evaluate the efficacy of traditional acupuncture vs. aspecific needle skin stimulation for persistent pain in subjects with spinal cord injury, at the end of treatment and at the 3 week follow-up.

Secondary objectives:

• Reduction of drug intake, at the end of treatment and at the subsequent follow-up;
• Reduction of anxiety/depression, at the end of treatment and at the subsequent follow-up;
• Improvement of quality of life, at the end of treatment and at the subsequent follow-up;
• Persistence of the effect of acupuncture 9 weeks after treatment.

Data concerning any adverse events, related to both experimental treatments of the trial, will also be collected.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized comparative trial

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

The statistician in charge for data analysis will be blind with respect to the identity of the assignment Groups (that will be coded so as not to be recognized) and will not be involved in filling data in the database to be analyzed.

Primary Purpose: Treatment

Condition

• Pain
• Spinal Cord Injuries

Intervention

• Other: Traditional chinese acupuncture
  Traditional chinese acupuncture (somatopuncture points, auriculotherapy points, craniopuncture and wrist-ankle acupuncture). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.
• Other: Aspecific needle skin stimulation
  Superficial needling of needles in skin areas outside the pain affected dermatome(s). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.

Study Arms

• Active Comparator: Traditional chinese acupuncture
  Traditional chinese acupuncture. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes.
  Intervention: Other: Traditional chinese acupuncture
• Sham Comparator: Aspecific needle skin stimulation
  Aspecific needle skin stimulation. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes.
  Intervention: Other: Aspecific needle skin stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 30, 2017): 114
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Persistent pain: NRS score >2 in at least 5 assessments in 5 consecutive days, despite usual antalgic management;
• Spinal cord injury due to any etiology (both traumatic and non-traumatic);
• Spinal cord injury of any neurological level, complete or incomplete, classifiable as Asia Impairment Score (AIS) A, B, C or D;
• Stable medical conditions;
• At least 1 month away from the spinal cord injury event.

Exclusion Criteria:

• Sporadic pain;
• Mechanical ventilation;
• Pregnancy;
• Disorders of consciousness;
• Incapacity to give informed consent in person.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Angela Morreale, MD; +39 0542 632811; morreale@montecatone.com

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT03170557
• Other Study ID Numbers: CE-17017
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Montecatone Rehabilitation Institute S.p.A.
• Study Sponsor: Montecatone Rehabilitation Institute S.p.A.
• Collaborators: Associazione Medici Agopuntori Bolognesi (A.M.A.B.)

Investigators

• Principal Investigator: Angela Morreale, MD; Montecatone Rehabilitation Institute S.p.A.

• PRS Account: Montecatone Rehabilitation Institute S.p.A.
• Verification Date: September 2020