Clinical trial NCT03170557: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Spinal Cord Injuries
Keywords: Persistent pain
Spinal cord injury
Acupuncture
Randomized Controlled Trial
RCT
Lead sponsor: Montecatone Rehabilitation Institute S.p.A.
Sponsor class: OTHER
Collaborators: name: Associazione Medici Agopuntori Bolognesi (A.M.A.B.)
First posted: 2017-05-31
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized comparative trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain reduction
timeFrame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Secondary outcomes:
measure: Persistence of pain reduction in Acupuncture arm
timeFrame: Follow-up 2 (9 weeks after closing session 12)
measure: Reduction of drugs intake
timeFrame: 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)
measure: Reduction of Anxiety/Depression
timeFrame: 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)
measure: Reduction of pain interference on sleep and quality of life
timeFrame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
measure: Improvement of quality of life
timeFrame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12)
Other outcomes:
measure: Patient satisfaction
timeFrame: Closing session 12 (6 weeks)
measure: Adverse events
timeFrame: Session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Locations:
city: Imola
country: Italy
facility: Montecatone Rehabilitation Institute S.p.A.
state: BO
Study officials:
affiliation: Montecatone Rehabilitation Institute S.p.A.
name: Angela Morreale, MD
role: PRINCIPAL_INVESTIGATOR
References: