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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Spinal Cord Injuries
• Intervention / Treatment: Other: Traditional chinese acupuncture; Other: Aspecific needle skin stimulation

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
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Imola, BO, Italy, 40026
      • Montecatone Rehabilitation Institute S.p.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional chinese acupuncture; Traditional chinese acupuncture. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reduction	Pain reduction of at least 2 points on the NRS scale	Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; Randomized Controlled Trial; RCT; Spinal cord injury; Persistent pain
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: CE-17017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No