Angled manual traction and usual care for cervical radiculopathy: rationale and a protocol for a pilot randomized controlled trial (pAMTLER)

Abstract

Background: Angled manual traction (AMT) is widely used for relieving moderate-to-severe cervicobrachial pain in patients with cervical radiculopathy (CR), yet its effectiveness has yet to be established by rigorous full randomized controlled trials (RCTs). We have designed an external pilot to evaluate the feasibility of a future large-scale, definitive RCT on AMT for CR.

Methods: 48 CR participants with cervicobrachial pain (numeric rating scale ≥ 4) will be enrolled in a five-period pilot RCT and randomly assigned to receive either usual care alone or AMT plus usual care for 4 consecutive periods (each period defined as 7 days). The primary outcome will be feasibility, focusing on enrolment rate, retention rate, and protocol adherence. The secondary outcomes include pain in the cervicobrachial region, upper extremity numbness, muscle weakness, upper extremity and neck function, analgesic consumption (non-steroidal anti-inflammatory drugs and opiates), work ability, quality of life, emotional well-being prior to administering treatment at each period's initial visit, as well as safety and intervention costs during the trial. We employ linear mixed-effect models on the efficacy-related outcome measures to assess the changes within and between groups over time, and determine the statistical trends of effectiveness.

Results: We expect the trial to be completed by June 2026, with successful pilot targets defined as achieving ≥ 25% enrolment, ≥80% adherence, ≥80% retention, and superior health outcomes in the AMT add-on arm compared with usual care.

Conclusion: This external pilot trial will provide robust data on feasibility and outcome variability for power calculations in the proposed future confirmatory RCT on AMT for CR. This pilot RCT will be invaluable to the design and management of the subsequent full-scale RCT.

Trial registration: Chinese Clinical Trial Registry (ChiCTR): https://www.chictr.org.cn/showproj.html?proj=236348 ChiCTR2400087289.

Keywords: angled manual traction; cervical radiculopathy; conservative management; pilot study; randomized controlled trial; study protocol.

Figure 1

pAMTLER study design. CR, cervical radiculopathy; R, randomized allocation; CG, control group; EG, experimental group; V, visit; Peri, period; NRS-CP_p24, having cervicobrachialgia over the previous 24 h on NRS; +1 d, data premitted to be collected within 1 day after the scheduled time. collecting data on efficacy- and cost-related outcome measures, followed by administering AMT; , collecting data on cost-related outcome measures, followed by administering AMT; , collecting data on efficacy- and cost-related outcome measures; , recording adverse events, adverse reactions and concomitant medication during the trial; , receiving usual care for 4 periods. Baseline assessment including socio-demographics (age, sex, education level, employment status, health insurance, etc.), medical history (comorbidities, concomitant medications, details related to the cervicobrachial pain episode, etc.) and physical examination (dominant hand, abnormal deep tendon reflexes, radiculopathy level shown on magnetic resonance imaging, etc.).

Figure 2

pAMTLER SPIRIT schedule. AR, adherence rate; DR, drop-out rate; RR, retention rate; CRE, completion rates of efficacy-related outcome measures; CRC, completion rates of cost-related outcome measures; NRS, cervicobrachial pain, upper extremity pain and numbness, neck pain, and shoulder pain graded by the numeric rating scale; QuickDASH, quick disabilities of the arm, shoulder, and hand questionnaire; NDI, neck disability index; analgesics consumption, NSAID consumption per period and opiate consumption per period; WPAI-CR, work productivity and activity impairment questionnaire: cervical radiculopathy; EQ-5D-5L, euroqol 5-dimensional descriptive system; SDS, Zung’s self-rating depression scale; SAS, Zung’s self-rating anxiety scale; AER, adverse event rates; ARR, adverse reaction rates; DMC, direct medical costs; DnMC, direct non-medical costs. In baseline assessment, socio-demographics (e.g., age, sex, education level, employment status, health insurance), medical history (e.g., comorbidities, concomitant medications, details related to the cervicobrachial pain episode), physical examination (e.g., dominant hand, abnormal deep tendon reflexes) and radiculopathy level are shown on magnetic resonance imaging.

Figure 3

Illustration of wearing semi-hard cervical collars. Wearing a cervical collar immobilizes the participant’s neck in forward flexion.

Figure 4

Illustration of pressing-kneading manipulation. white dot, mastoid process; red dot, the 7th cervical vertebra; dashed blue box, the nuchal region for pressing and kneading; black dashed line, transverse process line; white dashed line, zygapophyseal process line; red dashed line, pinous process line.

Figure 5

Illustration of traction manipulation. With the occiput and chin as contact points, apply a manual pulling force along the forward-flexion angle of the participant’s cervical spine, directed away from the body, until visible passive movement of the toes is observed.

Figure 6

Illustration of mechanical traction. Black dot, acromion; red dot, ear apex; white dot, vertex. Adjust the pillows to straighten the line connecting the acromion, ear apex, and vertex such that the participant’s head–neck is in the supine position and has the same traction angle as during manual intermittent traction.