The study was approved by the Ethics Committee of Liaocheng people’s Hospital. Consent forms were acquired from all patients. A total of 118 patients undergone ACDF during the period of 2016–2018 in Liaocheng People’s Hospital were assessed for eligibility. The inclusion criteria were as follows: (1) age over 18 years, (2) administration for over 1 day after surgery, (3) received an open reduction and internal fixation surgery. Since long-term diabetes is thought to have significant negative impact on spinal surgery [11] and cerebrovascular, neurological and psychiatric conditions are important factors to be assessed in our study, subjects with a history of diabetes for over 10 years or had a cerebrovascular, neurological, or psychiatric diseases were excluded. Among the 118 patients, 32 were excluded and 11 did not meet the inclusion criteria. 14 refused to participate and seven were not included for other reasons.
Randomization was performed using block randomization by a research scientist blind to the study. Equal numbers (n = 43 each group) of patients were assigned to either intervention group or control group. In the intervention group, massage treatment lasted four weeks. The treatment time we chose was mainly based on the time in hospital of the patients. In our hospital, the patients with anterior cervical discectomy and fusion are usually discharged one months after operation.
Foot massage
On the second day after surgery, patients in the intervention group were guided to lay in a supine position and given a whole-body relaxation procedure, which lasted for five minutes. Then each foot was given 5–10 min of massage using sweet almond oil, which is the most commonly used lubricant in massage. During the massage, the subjects’ feet were elevated using a pillow. The massage procedure was performed on both sides of the foot (plantar and dorsal sides), such that the fingers were placed on the dorsal side of the foot and the thumbs on the plantar side. Then, the plantar region of the foot was pressed with one thumb, stroking upward using less pressure. This was done first on the heel and was later continued on the toes, with the plantar side of the foot held facing the therapist so that the fingers of the therapist were placed on the dorsal side of the toe. This procedure was repeated 5–10 times in a single massage session. An experienced therapist performed massage for all patients to ensure consistent therapy. Routine care was also given to both groups of patients. The patients did not receive massage on other parts of the body. The massage was conducted every other day from 4 weeks.
Evaluation of pain, anxiety and quality of life
The questionnaires for evaluating pain, anxiety and quality of life were filled out by patients both before the intervention and after the 4-week intervention. Patients were guided to report neck pain assessed by neck pain visual analog scale (NP-VAS), in which patients were guided to indicate the pain intensity on a straight horizontal line of fixed length with the ends being defined as the extreme limits of pain intensities [12, 13]. The function of the neck was measured using Neck Disability Index (NDI), a questionnaire with 10 items regarding pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation [13].
Self-rating anxiety scale (SAS)[14] was also reported by the patients using a questionnaire consisted of 20 items, with a score of from 1 to 4 for each item. Their reported anxiety condition was categorized into: no anxiety (score < 50), mild anxiety (score = 50–59), moderate anxiety (score = 60–69) and severe anxiety (score > 69).
Assessment of quality of life was conducted using the QUALEFFO-41 subscales as the QUALEFFO‐41 subscales have been well validated to assess quality of life regarded to the orthopedic patients [15,16,17]. The QUALEFFO‐41 subscales consist of 41 questions to produce a total score with separate subscales for physical function, pain, general health perception, social function and mental function [18]. The total score and each subscale give a maximum score of 100, with higher scores representing increased severity.
Statistical analysis
Parametric data were presented as mean ± standard deviation (SD) and compared via the Student’s t-test or Wilcoxon signed rank test as appropriate. Non-parametric data were presented as mean and p values were derived from Chi-square test or Fisher’s exact test. Effect size was calculated using Phi, which can be computed by finding the square root of the chi-squared statistic divided by the sample size. Clinical relevant differences were set at effect size ≥ 0.4.